WO2020151359A1 - 一种可封堵的静脉导管装置 - Google Patents

一种可封堵的静脉导管装置 Download PDF

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Publication number
WO2020151359A1
WO2020151359A1 PCT/CN2019/120695 CN2019120695W WO2020151359A1 WO 2020151359 A1 WO2020151359 A1 WO 2020151359A1 CN 2019120695 W CN2019120695 W CN 2019120695W WO 2020151359 A1 WO2020151359 A1 WO 2020151359A1
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Prior art keywords
venous catheter
wire
needle tube
pluggable
lumen
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PCT/CN2019/120695
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English (en)
French (fr)
Inventor
董东生
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北京仰生恒泰科技有限责任公司
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Application filed by 北京仰生恒泰科技有限责任公司 filed Critical 北京仰生恒泰科技有限责任公司
Priority to JP2021543492A priority Critical patent/JP7241188B2/ja
Priority to US17/310,207 priority patent/US20220168548A1/en
Priority to EP19911406.7A priority patent/EP3915610A4/en
Publication of WO2020151359A1 publication Critical patent/WO2020151359A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0097Catheters; Hollow probes characterised by the hub
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113Mechanical advancing means, e.g. catheter dispensers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0606"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0004Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M2025/0079Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • A61M2025/0681Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/091Guide wires having a lumen for drug delivery or suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/36General characteristics of the apparatus related to heating or cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle

Definitions

  • the invention relates to a pluggable venous catheter device, which belongs to the technical field of medical equipment.
  • Venous puncture and associated intravenous infusion is the most commonly used technique in various clinical departments.
  • flexible intravenous catheters are most often used to indwell in the venous lumen.
  • the flexible intravenous catheter eliminates the cause
  • the intravenous catheter and the opening can easily cause blood coagulation due to local blood flow or stagnation, even if the tube is sealed with heparin and other anticoagulants.
  • Measures such as flushing the tube with physiological saline still cannot prevent the formation of thrombus in the lumen of the venous catheter, and the shedding of thrombus can lead to acute pulmonary embolism and life-threatening.
  • Patent application 201810470421.9 proposes to seal the front opening of the venous catheter through the external isolation of the sealing wire, and smoothly enter the lumen of the venous catheter through the guiding auxiliary sealing wire, but the sealing wire is between the guide passage opening and the rear opening of the venous catheter lumen
  • the intermittent travel is in a free state and has no coaxial guiding structure, and it is difficult for the plugging wire to easily enter the lumen of the venous catheter.
  • the present invention provides a pluggable intravenous catheter device.
  • a pluggable venous catheter device comprising: a needle tube for piercing the skin and vein wall, a needle tube seat in which the bottom of the needle tube is fixed; an venous catheter and an venous catheter seat sealedly connected with the rear end of the venous catheter; and a needle tube Passing through the sealing body on the venous catheter seat, the front part of the needle tube is located in the lumen of the venous catheter, and the front end of the needle tube is exposed from the front end of the venous catheter; and a slender movable blocking wire; part or all of the blocking wire is isolated from the outside
  • the isolation component also includes a guide passage, at least the front end of the guide passage is a straight tubular part; the front end of the guide passage is connected directly or through the lumen of the venous catheter holder with the lumen of the venous catheter, and the blocking wire can pass through the guide passage into the lumen of the venous catheter; At least the straight tubular part of the guide passage is coaxial with the
  • the function of the venous catheter means that it can not only inject fluids such as sterile water, liquid medicine, blood, etc., but also draw out body fluids such as venous blood, arterial blood, cerebrospinal fluid, and pleural effusion for inspection. Two-way access to the pleural cavity, subarachnoid cavity, abdominal cavity and other human cavities.
  • the guiding passage can be directly constituted by a through hole penetrating through the sealing body; or a hollow passage component can pass through the sealing body and or the venous catheter holder, and the inner cavity of the passage component is the guiding passage; the guiding passage can also be formed by the passage and The passages on other components are formed together.
  • the sealing body is cylindrical or bar-shaped as a whole to conform to the venous catheter base, and is made of deformable elastic material or hard material that is not easily deformed; the sealing body can also be an elastic part that is sealed with the venous catheter base and is easily deformed. It is composed of the hard part containing the guide passage; it can also be composed of a hard part that is sealed and not easily deformed with the venous catheter seat and a deformable elastic part containing the guide passage; the sealing body can be made of hard materials and the venous catheter
  • the seat is rotatably sealed and connected, or it can be a rotatably sealed connection between a rigid main body and an external elastic sealing ring and the venous catheter seat.
  • the cross-sectional shape is preferably a circle, and can also be approximately circular or polygonal.
  • At least a part of the guiding passage may extend to the lumen of the venous catheter seat, or even to the rear opening of the venous catheter.
  • the blocking wire and the guiding passage When the blocking wire and the guiding passage are stationary or moving relative to each other, they can directly contact with the fluid in the intravenous catheter socket.
  • the fluid in the venous catheter socket overflows through the gap between the guiding passage and the blocking wire and comes into contact with the blocking wire and the guiding passage. For the described fluid communication.
  • the inner surface of the guide passage can be provided with protrusions and or recesses that prevent fluid from overflowing when the plugging wire is stationary or moving axially, and it forms a transitional fit with the outer surface of the plugging wire, allowing gas to pass and not allowing fluid to pass; it and the plugging wire
  • the outer surface forms an interference fit, which neither allows fluid nor gas to pass.
  • the isolation member may be a deformable capsule structure extending from the sealing body; or a hollow thin wall that is easily deformed by force may include a tube shape, a sleeve shape, a disc shape, a blade shape, a butterfly wing shape, and a boat paddle.
  • Externally sealed flexible isolating parts including hollow shapes; or hollow hard isolating parts that are not easily deformed by force and can include tubular, disc-shaped, blade-shaped, butterfly-wing-shaped, and oar-shaped external sealing; or It is a hollow thin-walled flexible part that is easily deformed by force and a hollow hard part that is not easily deformed by force.
  • It can include tubular, sleeve-shaped, disc-shaped, blade-shaped, butterfly-shaped, and boat-shaped.
  • Externally sealed isolation component its inner cavity can be communicated with the part of the intravenous catheter socket that contacts the infusion fluid through the guiding passage.
  • Coincidence means that the two are collinear and coaxial, and the sealing wire is easier to pass through the guiding passage, the lumen of the venous catheter seat, and enter the front end of the venous catheter.
  • the slender blocking wire protruding from the front opening of the guide passage is easier to enter the lumen of the venous catheter, and finally the front opening of the venous catheter is blocked.
  • the guiding passages can also be all straight tubulars, or the straight tubular parts can be connected with other straight parts at an angle, or connected with other curved parts.
  • It also includes an infusion connecting tube, which can be connected with the venous catheter holder so that the lumen of the infusion connecting pipe can communicate with the lumen of the venous catheter holder.
  • the infusion connecting tube is connected to the lumen of the venous catheter holder through the sealing body, so that there is no branch on the side of the venous catheter holder, which facilitates better contact between the adhesive tape and the skin during use, and can also help reduce or eliminate veins.
  • the dead space in the lumen of the catheter holder also helps to reduce the vortex when flushing the lumen of the intravenous catheter holder with saline.
  • the straight tubular guiding passage or the straight tubular part of the guiding passage can be isolated and moved axially toward the venous catheter.
  • a solution for the combined needle tube and blocking wire pathway is: at least the straight tubular part of the guiding channel is coaxial with the venous catheter, and the needle tube passes through the straight tubular part of the guiding channel so that the front part of the needle tube is located in the lumen of the venous catheter; after the needle tube is withdrawn, The blocking wire can enter the lumen of the venous catheter through the straight tubular part of the guiding passage; the coaxial structure is preset, which saves the step of moving to be coaxial.
  • Another solution is to provide an unclosed needle tube passage, which passes through the sealing body, and the front part of the needle tube can be exposed from the front opening of the venous catheter through the front end opening of the needle tube passage; after the needle tube is withdrawn, the liquid medicine can be injected through the bottom opening of the needle tube passage The lumen of the venous catheter socket.
  • the sealing body is provided with a displacement cavity that can isolate the guiding passage from the outside.
  • the cavity is separated from the lumen of the venous catheter holder by a thin film that is easy to deform.
  • the membrane can be part of the sealing body or a connecting part of the venous catheter holder.
  • the part of the guide passages with different axes can be translated to the same after the needle tube is drawn out. The axis position, the cavity provides space for this movement.
  • the sealing body or the part with the guiding passage on it is connected to the venous catheter socket in a relatively rotatable connection, and the rotation axis of the sealing body is parallel to the central axis of the venous catheter;
  • the vertical distance between the rotation axes is equal to the vertical distance between the central axis of the venous catheter and the rotation axis.
  • a rotating handle is connected to the sealing body, and a limiting structure and/or a guiding structure matched with the rotating handle are provided on the venous catheter base.
  • the length of the straight tubular part of the guiding passage is greater than or equal to the distance from the front end opening to the rear end opening of the venous catheter.
  • the length of the straight tubular part of the guiding passage is greater than or equal to 1/2 of the length of the venous catheter.
  • a further reliable design is that the length of the straight tubular portion of the guide passage is greater than or equal to the length of the venous catheter.
  • the length of the straight tubular portion of the guide passage is greater than or equal to the distance from the front end opening of the venous catheter to the front end opening of the venous catheter.
  • At least one circumferential area between the guide passage and the outer surface of the blocking wire is in fluid-tight contact to prevent the liquid medicine from entering the inner cavity of the isolation component.
  • the plugging wire isolating member is connected with a fluid circulation member, and the inner cavity of the isolating member is in fluid communication with the inner cavity of the fluid circulation member.
  • the tail section of the slender plugging wire is connected with a control handle, and the bottom end of the plugging wire isolation component is sealed with a part of the control handle.
  • the inner cavity of the control handle is provided with a fluid turnover component to seal
  • the inner cavity of the plugging isolation part is in fluid communication with the inner cavity of the fluid circulation part.
  • the slender closure wire is hollow at least in the front section to form the lumen of the closure wire, and the top end is the blind end; the closure wire with the hollow front section will not increase significantly The deflection of the venous catheter.
  • the elongated plugging wire is hollow as a whole to form the inner cavity of the plugging wire, the end is provided with an opening, the top is a blind end, and the front section is provided with at least one side hole;
  • the liquid medicine can enter the lumen of the plugging wire through the opening at the end and then flow out from the side hole, and then inject into the vein through the intravenous catheter.
  • the slender plugging wire is hollow at least in the bottom section to form the inner cavity of the plugging wire.
  • the inner cavity of the plugging wire can be placed with a larger deflection but a smaller outer diameter.
  • the assisting guide wire can enter the inner cavity of the blocking wire to push the blocking wire forward better, and it can also assist backward after setting the corresponding connection.
  • the assisting guide wire does not enter the lumen of the intravenous catheter or the length of the entry into the lumen is less than 1/2 of the length of the intravenous catheter.
  • the assisting guide wire guides the movement of the top end of the blocking wire to the front opening of the venous catheter, and then the assisting guide wire can be withdrawn to the initial position or the rear opening of the venous catheter, or the assisting guide wire will accompany it after the closure of the venous catheter is completed Withdraw to the initial position.
  • the assisting guide wire can assist the tip of the sealing wire to move to the rear opening of the venous catheter. At this time, the assisting guide wire stays at the rear opening of the venous catheter and does not move forward, and then drives the sealing wire to move to the front opening of the venous catheter alone. In this process, the venous catheter serves as a guide for the sealing wire.
  • the assistance of the guide wire to the plugging wire includes pushing and or supporting.
  • the top end of the hollow plugging wire can also be set as a non-blind end.
  • the outer surface of the top portion of the plugging wire blocks the front end opening of the venous catheter, and the top portion of the guide wire is assisted to block the top end opening of the hollow plugging wire.
  • the bottom end of the plugging wire and the assisting guide wire can be respectively connected with a manipulation handle for applying external force, and the bottom end of the plugging wire isolation component is sealed and fixedly connected with the plugging wire directly or through the manipulation handle of the plugging wire.
  • the assisting guide wire is also placed in an isolation component.
  • the assisting guide wire can be directly fixedly connected to the bottom end of the isolation component, or through the assisting guide wire.
  • the control handle is sealed and fixedly connected with the bottom end of the isolation component.
  • the guide wire and the isolation component outside the venous catheter base also includes a shell assembly connected with the guiding passage; the shell assembly can be elongated, disc-shaped, etc., with corresponding grooves set in it.
  • the grooves and other containment and guiding structures; the plugging wire and the isolation component are at least partially conformally located in the shell assembly.
  • the needle tube seat is connected with an elastic component that can drive the venous catheter seat to move axially.
  • the needle tube seat is connected with a blade-shaped handle with a curved front end.
  • the curved front end and the finger can eliminate the back of the needle tube caused by the elastic component.
  • the needle tube seat is connected with two leaf-shaped handles with curved left and right front ends extending to the upper end surface of the venous catheter seat; the venous catheter seat is provided with a protruding or recessed matching structure between the two leaf-shaped handles.
  • a heat generating element is connected to the plugging wire and or the guiding passage.
  • the heat-generating element can be a metal heating wire or an element that generates heat through indirect contact electromagnetic induction; the heat-generating element can be embedded in a hollow plugging wire, and the bottom end of the plugging wire is connected to the power supply and electronic control module to block Under the condition, the temperature of the venous catheter in the venous lumen, especially the tip part, is equal to or higher than the temperature of the blood in the vein, so as to effectively avoid blood clotting on the venous catheter.
  • various control handles such as rotating handles, that are acted on by external forces can be manually driven or driven by a driving device including a motor.
  • the blocking wire enters the lumen of the venous catheter smoothly under the premise that it is guided continuously or intermittently but coaxially guided.
  • the plugging wire completely seals the top opening of the venous catheter, blood cannot enter the lumen of the venous catheter, and completely eliminates the risk of thrombosis in the lumen of the venous catheter.
  • the conical tip of the blocking wire partially extends out of the top opening of the venous catheter in the blocked state, thereby eliminating the local blood flow dead space and minimizing the occurrence of wall thrombosis, fibrin sheath and venous thrombosis.
  • At least the heat generating element arranged at the top of the blocking wire can significantly increase the temperature at the top opening of the venous catheter and avoid blood clotting to the greatest extent.
  • the medicinal liquid flowing through the heat generating element at the top of the plugging wire is not only beneficial to the stability of the human body's heat balance, but also to the greatest extent to avoid blood coagulation due to low temperature.
  • At least the heat-generating element arranged at the top of the blocking wire can avoid the risk of infection caused by the reduction of white blood cell activity due to local low temperature.
  • Figures 1A, 1B, 1C, 1D, 1E, 1F schematic diagrams of the structure of Embodiment 1;
  • 3A, 3B, 3C, 3D schematic diagrams of the structure of Embodiment 3;
  • 5A, 5B, 5C, 5D, 5E schematic diagrams of the structure of Embodiment 5;
  • 6A, 6B, 6C, 6D schematic diagrams of the structure of Embodiment 6;
  • Figures 9A and 9B schematic diagrams of the structure of Embodiment 9;
  • Figure 11 a schematic diagram of the structure of embodiment 11;
  • 15A, 15B schematic diagrams of the structure of Embodiment 15;
  • the first embodiment of the present invention includes: a rigid needle tube 1, a needle tube seat 16, a venous catheter 2, a venous catheter for piercing the skin S and the vein wall V Seat 23, sealing body 25, blocking wire 3, blocking wire guide passage 40, isolation component 5;
  • the inner hollow of the needle tube 1 is the needle tube lumen 10
  • the front part 11 of the needle tube is located in the venous catheter lumen 20, and the sharp tip of the needle tube during puncture 111 is exposed from the front end opening 201 of the IV catheter;
  • the needle tube lumen 10 is provided with an opening 101 at the front end of the needle tube, and the front part 11 of the needle tube is provided with a lateral opening 102 adjacent to the front end 111 of the needle tube;
  • the needle tube connection part 12 is located in the area of the front end 231 of the IV catheter seat 23 ,
  • the middle part of the needle tube 13 is located in the inner cavity 230 of the venous catheter base, and the needle through
  • the bottom 15 of the needle tube is fixed in the needle base 16 and the needle base 16 is connected with a needle base handle 17; a relatively flexible hollow venous catheter 2 It can be made of PU, FEP and other materials. It is composed of a front part 21 and a back part 22. The front part 21 of the venous catheter is provided with a tapered tip 211.
  • the liquid medicine flows into the vein V from the front end opening 201 through the venous catheter lumen 20.
  • the intravenous catheter lumen 20 communicates with the intravenous catheter holder lumen 230 through the rear end opening 202; between the front end 231 and the rear end 232 of the intravenous catheter holder 23 are an upper end surface 233, a lower end surface 234, a left side surface 235, and a right side surface 236.
  • the inner cavity 230 has a smaller front opening 2301 at the front end 231 and a larger rear opening 2302 at the rear end 232.
  • the front end opening 2301 is sheathed with a hollow venous catheter rear part 22, and the venous catheter holder rear opening 2302 Packed with a sealing body 25;
  • the left side of the venous catheter base 235 has a hollow infusion side branch 2351 connected to the connecting tube 24, the inner cavity 230 of the venous catheter base communicates with the connecting tube inner cavity 240;
  • the front end surface 251 of the sealing body 25 is adjacent to the venous catheter base In the inner cavity 230, the rear end 252 faces outward, and the sealing body 25 is formed by connecting a hard part 25a and an elastic part 25b.
  • the hard part 25a can be made of resin PC, AS, ABS, etc.
  • the elastic part 25b can be made of silicone rubber, polyurethane, etc.
  • the elastic part 25b can close and seal the area through which the needle tube 1 passes after the needle tube 1 is pulled out;
  • the hard part 25a of the sealing body is provided with a plugging wire guide passage 40, and the front section of the guide passage 40 is a straight tubular part 41.
  • the rear section 42 is in oblique communication with the front section 41, and the guide passage 40 is provided with a front end opening 401 and a rear end opening 402;
  • the elongated plugging wire 3 can enter the guide passage 40 from the rear opening 402 of the guide passage;
  • the plugging wire 3 It is a deformable bladder-shaped thin-walled isolation member 5, which can be made of flexible film materials such as silicone rubber, polyurethane, polyethylene, EVA, PET, etc.
  • the front end 51 of the isolation member is provided with an opening 501, and the rear end 52 is a blind end.
  • the front end 51 of the component is sealed and sleeved on the cylindrical or flat external protrusion 254 of the hard portion 25a of the sealing body 25, and can be sealed and connected by bonding, thermal welding, ultrasonic welding, etc.
  • a part of the rear section 42 of the guide passage is located in the outer protrusion 254, and the rear end opening 402 of the guide passage is located on the rear face 2541 of the outer protrusion 254; the blocking wire 3 may be in direct contact and or fluid with the inner cavity 230 of the venous catheter holder
  • the connected parts are all located in the inner cavity 50 of the isolation member.
  • the end 341 of the plugging wire is completely located in the inner cavity 50 of the isolation member.
  • the needle tube 1 with the venous catheter 2 pierces the skin surface S, subcutaneous tissue S1, and the vein wall V.
  • the sharp tip 111 of the needle tube enters the venous lumen V0, and the venous blood flows into the needle tube lumen 10 and is on the side of the tip of the needle tube.
  • the opening 102 is observed by the operator through the transparent venous catheter 2 to confirm the success of the puncture.
  • the needle tube center axis L0, the center axis of the straight tubular part of the guide passage L2, and the venous catheter center axis L1 are three lines collinear, and a part 14a of the needle tube penetrating part 14 is located in the guide path of the hard part 25a of the sealing body In the straight tubular portion 41, the other part 14b of the needle tube passing part 14 passes through the elastic part 25b of the sealing body; at this time, the front end opening 401 of the guiding passage is occupied by the needle tube passing part 14a, and the blocking wire 3 cannot enter the intravenous catheter socket inner cavity 230.
  • the needle tube 1 is withdrawn, and the elastic part 25b of the sealing body closes and seals the linear area 253 through which the needle tube passes due to the elastic deformation of the material.
  • the front end opening 401 of the guiding passage Connected with the venous catheter socket lumen 230; as shown in Figure 1D, because the straight tubular portion 41 of the guiding passage is coaxial with the venous catheter 2, that is, the central axis L2 of the straight tubular portion of the guiding passage is collinear with the central axis L1 of the venous catheter, and the sealing wire 3 Enter the intravenous catheter socket lumen 230 under the coaxial guidance of the straight tubular portion 41 of the guiding passage; as shown in Figure 1E, the blocking wire 3 enters the intravenous catheter lumen 20 through the venous catheter rear opening 202; as shown in Figure 1F The blocking wire 3 finally blocks the front-end opening 201 of the venous catheter, and the isolation
  • the part of the sealing wire 3 located in the lumen 20 of the venous catheter is the front section 31, the part located in the lumen 230 of the venous catheter base is the middle section 32, and the part located in the straight tubular portion 41 of the guide passage It is the posterior section 33, and the rest is the tail section 34.
  • the end 341 of the tail section 34 is located in the inner cavity 50 of the isolation member.
  • the top end 311 of the front section 31 of the blocking wire is tapered and protrudes from the front end opening 201 of the venous catheter to the greatest extent.
  • the blood vortex here during the blocking; the top 311 of the blocking wire and the front opening 201 of the venous catheter are in blood blocking contact, that is, the blood cannot pass through the gap between the two, which can be an interference fit or a conformal fit.
  • the plugging wire 3 in this embodiment is a solid wire shape, which can be formed from resin materials such as PU, PA, PET, PDFE using extrusion or injection molding processes, or metal materials such as nickel-titanium alloys can be selected. Pinch the flexible film-shaped isolation member 5 to fix the plugging wire 3 in its inner cavity 50, and drive the plugging wire 3 forward or back. Specifically, the rear end 52 of the isolation member and the plugging wire tail in it can be pinched Section 34 ends 341 part.
  • the biggest difference from Embodiment 1 is that the central axis L2 of the straight tubular portion 41 of the guide passage and the central axis L1 of the venous catheter in the initial state Different shafts but in parallel relationship.
  • Fig. 2A shows that the needle tube socket 16 is located below the isolation member 5.
  • the upper end surface 233 of the venous catheter socket 23 is provided with an arched window 2331, and a part of the hard part 25a of the sealing body is exposed in the arched window 2331.
  • a handle 255 is connected to the hard part 25a of the sealing body, and the handle 255 is connected to the hard part 25a of the sealing body through the neck 2551;
  • the cross-sectional view of FIG. 2B shows that the front end 311 of the plugging wire is located in the guide passage 40 and is adjacent to the rear end opening 402.
  • the front-end opening 401 of the guiding passage faces the boss 2303 of the venous catheter holder lumen 230, and the sealing wire 3 cannot enter the venous catheter lumen 20; the hard part 25a and the elastic part 25b of the sealing body are double-injected, bonded, and interference
  • the two can move synchronously; when there is no needle tube 1 interference in the intravenous catheter lumen 20, the driving handle 255 rotates from the left side to the right side of the arched window 2331, and the sealing body 25 can
  • the centerline L3 of the venous catheter socket 23 is the axis of rotational displacement; Fig.
  • FIG. 2C shows that the needle tube 1 is withdrawn from the sealing body 25, the linear area 253 is closed and sealed to the outside, and the needle tube socket on the sealing body 25 is recessed 256 void, at this time the linear area 253 is still located on the extension line of the central axis L1 of the venous catheter; as shown in Figure 2D, the operator's finger P acts on the handle 255 on the hard part 25a of the sealing body, and the driving handle 255 rotates from the left side of the arched window 2331 to the right side, the neck When 2551 cannot move, it rotates into position.
  • the central axis L2 of the straight tubular guide passage 40 is collinear with the central axis L1 of the venous catheter, as shown in Fig.
  • the finger P can drive the front end of the plugging wire by applying force on the isolation component 5 311 moves forward in the direction of the arrow on the central axis L1 of the venous catheter;
  • Figure 2F shows that the top end 311 of the front segment 31 of the blocking wire tapers and protrudes from the front-end opening 201 of the venous catheter, thereby sealing the venous catheter 2 and isolating the component 5.
  • the cross-sectional view 2G shows the initial state, the needle tube 1 is located in the intravenous catheter lumen 20, and the central axis L2 of the straight tubular guide passage 40 and The central axis L1 of the venous catheter is in a different axis but in a parallel relationship, and the rotation axis L3 is located in the middle of the two;
  • the cross-sectional view 2H shows that the needle tube 1 is withdrawn from the sealing body 25, and there is no interference factor of rotational movement at this time;
  • the cross-sectional view 2I shows the state after the rotation is in place ,
  • the central axis L2 of the straight tubular guide passage 40 and the central axis L1 of the venous catheter are in a collinear position.
  • the guide passage 40 of this embodiment is straight, without bending and inclined parts, and the entire rotation is performed under the premise of isolation from the external environment.
  • the opening 202 at the rear end of the tube is sufficient.
  • the biggest difference from Embodiment 2 is that the central axis L2 of the straight tubular guide passage 40 on the sealing body 25 is collinear with the central axis L1 of the venous catheter through an externally isolated rotation method.
  • the guide passage 40 is composed of an independent hollow passage member 4, and the collinearity is achieved by means of externally isolated translation instead of rotation.
  • the access member 4 is sheathed in the tubular protrusion 2332.
  • the access member 4 has an extension 43 protruding from the outer end surface 2333 of the tubular protrusion of the IV catheter base, and the isolation member The inner surface of the front end 51 is sealed with the outer surface of the tubular protrusion 2332, and the passage member extension 43 is located in the inner cavity 50 of the isolation member.
  • the passage member 4 can be driven to be displaced relative to the tubular protrusion 2332 by the external force acting on the extension section 43, and the passage member 4 is bent
  • the front section of the hollow part is the straight tubular section 41 of the guide passage
  • the rear section 42 is obliquely connected with the front section 41
  • the slender plugging wire 3 enters the rear section 42 of the guide passage at the front section 31.
  • the central axis of the straight tubular section 41 of the guide passage L2 is parallel to the central axis L1 of the venous catheter but does not have the same axis.
  • the sealing body 25 can be completely made of elastic material and does not need to be rotated; in the initial state, the access member 4 cannot move downward due to the obstruction of the needle tube 1.
  • the needle tube 1 In use, when the venipuncture is successful, the needle tube 1 starts to be withdrawn from the sealing body 25, as shown in FIG. 3B, the needle tube 1 will no longer hinder the descending of the access member 4 after being withdrawn.
  • the finger P squeezes the area near the front end 51 of the partition member, so that the film-like flexible partition member 5 partially contacts the extension section 43 of the passage member and pushes downward forcefully, the passage member 4 descends to the central axis of its straight tubular portion 41 L2 is coaxial with the central axis L1 of the venous catheter.
  • the front end of the straight tubular portion 41 of the access component is against the inner wall of the venous catheter seat and cannot continue to move.
  • the front segment 31 of the blocking wire extends from the front-end opening 401 of the guide passage along the central axis L1 of the venous catheter and enters the lumen 20 of the venous catheter. Due to reliable isolation, microorganisms and other foreign bodies in the external environment will not be affected by this operation. It is brought into the venous catheter socket inner cavity 230, that is, it will not enter the venous lumen V0; of course, the tubular protrusion 2332 on the venous catheter socket 23 can also be provided on the left side 235 or the right side 236 of the venous catheter socket.
  • the biggest difference in the coaxial position of the catheter center axis L1 is that the straight tubular passage member 4, the needle tube penetrates the elastic part 25b of the sealing body and the hard part 25a of the sealing body, and is connected to the inner wall of the venous catheter socket 23 in a sealed manner; adjacent to the right side surface 236 of the venous catheter socket, There is a cavity 257 between the elastic part 25b and the hard part 25a of the sealing body, and the right cavity 257 is an area where the needle tube 1 of the elastic part 25b can pass through with the shape and volume.
  • the elastic part 25b of the sealing body can be translated relative to the hard part 25a for external sealing.
  • the front edge of the elastic part 25b of the sealing body is sealedly connected with the front edge of the hard part 25a through a flexible diaphragm.
  • the left part 25c of the diaphragm is bent, the right part 25d is relatively stretched, and the right cavity 257 is separated from the inner cavity 230 of the venous catheter socket by the right part 25d of the sealing diaphragm;
  • the access component 4 has an extension 44 Protruding from the rear end of the elastic part 25b of the sealing body, the outer surface of the extension section 44 is in a sealed connection with the inner surface of the front end 51 of the isolating member; when there is no interference of the needle tube 1, the external force acts on the extension section 44 of the passage member to make the elastic part 25b of the sealing body guide together
  • the passage 40 is translated.
  • the elastic portion 25b of the sealing body along with the guide passage 40 translates to the right cavity 257 and fills the cavity 257, while the space before the elastic portion 25b is idle to form a left cavity 258; the sealing diaphragm left
  • the side portion 25c is stretched, and the right portion 25d is bent relative to the front; at this time, the central axis L2 of the guiding passage and the central axis L1 of the venous catheter are in a coaxial position.
  • the blocking wire 3 protruding from the front end opening 401 of the guiding passage can smoothly enter the venous catheter lumen 20, and finally the venous catheter front end opening 201 is sealed.
  • the solution shown in this embodiment is that after the central axis L2 of the straight tubular guide passage 40 rotates to a position collinear with the central axis L1 of the venous catheter, the guide passage 40 moves axially, and finally the front end opening 401 of the guide passage is closer or directly Contact with the rear end opening 202 of the venous catheter, so as to better ensure the entry of the blocking wire 3.
  • Fig. 5A is a cross-sectional view showing that the needle tube 1 and the passage member 4 penetrate through the sealing body 25.
  • the front end of the needle tube seat 16 is embedded in the recess 256 of the sealing body 25.
  • the sealing body 25 is composed of a hard part 25a and an elastic part 25b.
  • an extension 45 protrudes from the rear end of the hard part 25a of the sealing body, and the rear end of the hard part 25a of the sealing body that wraps the access member 4 has an extension part 259 protruding from the rear end 232 of the venous catheter base, extending
  • the part 259 has a thin-walled end 2591 and a handle 2592, and the outer surface of the thin-walled end 2591 of the extension part 259 is in a sealed connection with the inner surface of the front end 51 of the isolation member.
  • the needle tube 1 is withdrawn from the elastic part 25b of the sealing body, the linear area 253 that the needle tube 1 passed through is closed and sealed to the outside, and the recessed part 256 of the needle tube seat 16 was previously accommodated.
  • the external force acts on the extension 259 or the handle 2592 of the rigid part 25a of the sealing body, and the central axis L2 of the guide passage 40 is moved to a position collinear with the central axis L1 of the venous catheter through rotational displacement, as shown in Figure 5C,
  • the blocking wire 3 can move in the direction indicated by the arrow, that is, the direction coaxial with the central axis L1 of the venous catheter.
  • the external force passes through the isolation component 5
  • the outer surface acts on the extension part 45 of the passage member 4 to move the isolated axial direction forward until the front end opening 401 of the guiding passage is butted with the rear end opening 202 of the venous catheter, and the sealing wire 3 can smoothly enter the lumen 20 of the venous catheter;
  • the passage member 4 translates in the channel in the hard part 25a of the sealing body, which may be translation under the premise of sealing contact; one or more lateral openings 403 are provided in the part where the passage member 4 enters the inner cavity 230 of the intravenous catheter base.
  • the medical solution can enter the intravenous catheter socket lumen 230 through the infusion side branch (not shown in the figure) and then enter the guiding passage 40 and the intravenous catheter lumen 20 through this opening, without the need to withdraw the access component 4.
  • the blocking wire 3 can smoothly enter the intravenous catheter lumen 20 and block the front end opening 201.
  • the whole process of the blocking wire 3 is carried out under a straight tube and continuous guidance.
  • the sealing body 25 is provided with a needle tube passage 140.
  • the needle tube passage 140 will not close, but will pass
  • the male connector 25e is docked with the connector 241 of the connecting tube 24 for medical fluid infusion, so that the medical fluid in the connecting tube cavity 240 flows through the needle tube passage 140 into the venous catheter socket lumen 230, and then enters the venous catheter lumen 20.
  • Fig. 6A shows that in the initial state, the isolating component 5 is up, the needle tube seat 16 is down, and the needle tube seat handle 17 extends on the right side.
  • the needle tube 1 is located in the sealing body 25 made of hard material.
  • the needle tube seat 16 is partially embedded from the seal Inside the male connector 25e protruding from the rear end surface 252 of the body 25; the central axis L2 of the straight tubular guide passage 40 is parallel to the central axis L1 of the venous catheter but not axially.
  • Fig. 6B shows that when the needle tube 1 is withdrawn, the needle tube passage 140 in the sealing body 25 appears, and the female connector 241 at the front end of the connecting tube 24 is sealed and butted with the male connector 25e, and the liquid medicine can be started to flow into the intravenous catheter in the arrow direction Cavities 20.
  • Fig. 6C shows that the central axis L2 of the straight tubular guide passage 40 is collinear with the central axis L1 of the venous catheter through a rotating operation, and the sealing wire 3 blocks the front end opening 201 of the venous catheter, and blood in the venous lumen V0 cannot enter the venous catheter At the same time, the liquid medicine cannot enter the venous lumen V0; in this example, the guiding passage 40 is a straight tube in the whole process, and no independent part is provided, but is formed by the internal passage of the sealing body 25.
  • 6D shows that when the blocking wire 3 is recovered into the guide passage 40, the medical solution can flow into the intravenous catheter lumen 20 in the direction indicated by the arrow.
  • the back end of the sealing body 25 is provided with a communicating tube 242.
  • the communicating tube 242 is located below the isolation member 5, and the communicating tube 242
  • the side branch 243 is provided.
  • the inner cavity 2430 of the side branch of the connecting tube can be used for infusion of liquid medicine.
  • the bottom end of the connecting tube 242 is connected with a joint 244.
  • the joint 244 is equipped with an elastic sealing plug 245.
  • the needle tube 1 passes through the elastic sealing plug 245 and the inner cavity of the connecting tube. 2420 and the needle tube passage 140 in the sealing body 25, the needle tube seat 16 is connected with a handle 17 located outside the joint 244.
  • the linear area 2451 through which the needle tube 1 passes on the elastic sealing plug 245 is closed and sealed to the outside.
  • the liquid medicine can pass through the side branch lumen 2430 of the connecting tube, the inner lumen 2420 of the connecting tube and or The elastic sealing plug 245 pierced by the infusion needle tube (not shown in the figure) is injected, and the liquid medicine flows into the inner cavity 230 of the venous catheter holder in the direction indicated by the arrow in the figure.
  • the connecting pipe 242 is located above the isolation member 5, the bottom end of the connecting pipe 242 is connected with a joint 244 to seal the outside, and the side branch 243 of the connecting pipe can be connected to the infusion
  • the pipeline may be blocked by the infusion connector (picture omitted).
  • the medical solution when the medical solution needs to be infused again, the medical solution can pass through the side branch lumen 2430 of the connecting tube, the inner lumen 2420 of the connecting tube and or be pierced by the infusion needle tube (not shown).
  • the sealing plug 245 is injected, and the liquid medicine flows into the inner cavity 230 of the venous catheter holder in the direction indicated by the arrow in the figure.
  • the scheme of this embodiment emphasizes that the inner cavity of the connecting tube 24 for infusion of medical solution enters the inner cavity 230 of the venous catheter socket through the infusion channel 250 on the sealing body 25.
  • the needle tube base 16 is located below the isolation member 5
  • the connecting tube 24 for infusion of the medical solution is connected from the rear end 252 of the sealing body 25, and the upper end 233 of the intravenous catheter base 23 is provided with an arched window 2331 and an arched window 2331
  • a part of the hard part 25a of the sealing body is exposed inside, a handle 255 is connected to the hard part 25a of the sealing body, and the handle 255 is connected to the hard part 25a of the sealing body through a neck 2551.
  • the cross-sectional views 8B and 8C with different partial cross-sectional perspectives show that the front end 311 of the blocking wire is located in the guiding passage 40 and adjacent to the rear opening 402, and the front opening 401 of the guiding passage faces the inner wall of the venous catheter socket 23, and the blocking wire 3 cannot enter the vein
  • Figure 8D shows that when there is no interference of the needle tube 1 of the intravenous catheter lumen 20, the driving handle 255 is rotated from the left side of the arched window 2331 through the right side by 270° to the lower side, so that the sealing body 25 can be aligned with the centerline of the intravenous catheter seat 23 L3 is the axis of rotational displacement; the central axis L2 of the straight tubular guide passage 40 is collinear with the central axis L1 of the venous catheter.
  • Fig. 8E shows that the top end 311 of the front segment 31 of the blocking wire tapers and protrudes from the front end opening 201 of the venous catheter, thereby sealing the venous catheter 2 and the isolating component 5 is axially compressed and deformed to both sides.
  • the length L8 of the straight tubular guide passage 40 is greater than or equal to the distance L5 between its front end opening 401 and the rear end opening 202 of the venous catheter. This design can ensure that the blocking wire 3 is in the straight tubular guide passage 40 The venous catheter lumen 20 can continue to guide the sealing wire 3 by coaxially advancing smoothly under the restriction.
  • a test-proven solution is that the length L8 of the straight tubular guide passage 40 is greater than or equal to 1/2 of the length L6 of the venous catheter 2, which can avoid the use of the curved guide passage 40, the curved part of the sealing wire
  • the shaping action of 3 causes resistance when it enters the lumen 20 of the intravenous catheter.
  • a more reliable size selection is that the length L8 of the straight tubular guide passage 40 is greater than or equal to the length L6 of the venous catheter 2 to ensure that the blocking wire 3 is not affected by the possible bending part of the guide passage 40 during its travel.
  • a more reliable solution is that the length L8 of the straight tubular guide passage 40 is greater than or equal to the distance L7 from the front end opening 401 to the front end opening 201 of the venous catheter, so that even the elongated blocking wire 3 that is easily bent is straight After the tubular guiding passage 40 is shaped, it can still ensure smooth entry into the venous catheter 20.
  • Fig. 9B is a partially enlarged view showing that there are two rings of circumferential protrusions 404 in the front end opening 401 of the guide passage.
  • the circumferential protrusions 404 are in interference contact with the outer surface of the sealing wire 3 to prevent the liquid medicine or blood in the inner cavity 230 of the intravenous catheter holder from passing between the two. Enter the inner cavity 50 of the isolation component.
  • the biggest difference from the previous embodiment is that the rear end 52 of the isolation member is connected with a hollow handle 53, and the front opening 531 of the inner cavity 530 of the handle is sleeved with a bladder-shaped easy-expandable fluid turnover member 54.
  • the inner cavity 540 of the fluid circulation component is communicated with the inner cavity 50 of the isolation component through the communication hole 5054.
  • the fluid circulation component 54 has not expanded yet, and the end 341 of the plugging wire tail section 34 is fixed in the front opening 531 of the inner cavity 530 of the handle.
  • the control handle 53 when the finger (not shown) drives the control handle 53 to advance the plugging wire 3, the isolating member 5 is compressed and deformed, and the gas in the inner cavity 50 is pressed into the inner cavity 540 of the expanded fluid circulation member to avoid gas compression Resistance is generated to interfere with the forward movement of the plugging wire 3;
  • the control handle 53 can be flat, cylindrical, ellipsoidal, etc.
  • the elongated plugging wire 3 is hollow at least in the front section 31 to form the plugging wire lumen 30, and the top end 311 is the blind end; it enters the intravenous catheter under the blocked state.
  • the cavity 20 is the anterior segment 31 of the blocking wire. Its hollow interior can greatly reduce the deflection of the anterior segment, thereby avoiding the increase of the overall deflection after intrusion with the venous catheter 2 and reducing the possible crushing damage of the venous catheter 2 to the vein wall V during the closure .
  • a heat generating element can be provided in the front section 31 of the plugging wire 3 or the entire plugging wire 3 (the figure is omitted).
  • the heat generating element can be a metal heating wire or an element that generates heat through indirect contact electromagnetic induction; in the blocked state, the heat generating element makes the temperature of the venous catheter 2 in the venous lumen V0, especially the front end 211, equal or higher The temperature of the blood in the vein is lowered, thereby effectively avoiding blood clotting on the venous catheter 2.
  • the solution of this embodiment is to make the inner cavity 30 of the blocking wire used as a path for infusion of medical liquid.
  • the elongated plugging wire 3 is hollow to form a plugging wire lumen 30, the end 341 of the plugging wire tail section 34 is provided with an opening 3410, the top end 311 is a blind end, and the front section 31 is provided with at least one side hole 310; the end opening 3410 of the plugging wire is connected to the inner cavity 550 of the hollow handle 55; the front end 551 of the handle 55 is thin, and the inner hollow sleeve of the front end 551 is provided with the end section 34 of the plugging wire, and the inner cavity 550 of the handle is filled with elastic Sealing plug 56;
  • This figure shows the blocked state after the needle tube 1 is withdrawn, and the venous blood cannot flow back to the venous catheter seat lumen 230; the enlarged view on the left side of the figure shows the front side hole 310 of the blocking wire is next to the venous catheter 2 Inner wall.
  • the control handle 55 is pulled to extend the isolation member 5, and the front section 31 of the blocking wire is drawn out from the rear end opening 202 of the venous catheter.
  • the external needle tube is inserted into the elastic seal of the inner cavity 550 of the control handle. Stopper 56 for infusion of liquid medicine (the figure omitted), the liquid medicine enters the sealing wire lumen 30 through the control handle lumen 550, and then flows into the venous catheter socket inner cavity 230 from the front side hole 310 of the sealing wire as shown by the arrow in the figure .
  • This example shows the structure in which the central axis L2 of the guide passage 40 is collinear with the central axis L1 of the venous catheter through rotation.
  • the biggest difference is that the sealing wire 3 and the isolation component 5 are sheathed with a housing assembly 8 that is convenient for driving.
  • the components of the shell assembly 8 can precisely control the movement of the plugging wire 3 and the assisting guide wire 6 inside.
  • Figures 13A and 13B show that the structure of the venous catheter holder 23 is roughly the same as that of the second embodiment.
  • the central axis L2 of the straight tubular guide passage 40 and the central axis L1 of the venous catheter are not coaxial but parallel.
  • the needle holder 16 is located in the isolation part.
  • the upper end 233 of the venous catheter socket 23 is provided with an arched window 2331, and a part of the hard part 25a of the sealing body is exposed in the arched window 2331. The difference is that the rear end of the hard part 25a of the sealing body protrudes from the venous catheter socket.
  • the extension part 259 of the rear end surface 232 is sleeved with the connecting part 834 of the lower shell part 83 of the shell assembly 8;
  • the shell assembly 8 is in the shape of a disc as a whole, consisting of the lower shell part 83, the middle shell part 82 and the upper shell
  • the part 81 and the assembly plate 84 are combined; in the initial state shown in Figures 13A and 13B, the lower shell part 83 is on the upper, the middle shell part 82 is in the center, the upper shell part 81 is on the bottom, and the assembling disc 84 passes through the center of the lower shell part.
  • the middle of the arched window 2331 is provided with an upwardly extending front and rear longitudinal bridge-like stiffener 2334, and the hard part 25a of the sealing body is provided with a cylindrical limiting protrusion 2594, which is cylindrical limiting
  • the position protrusion 2594 does not expose the arched window 2331, and the cylindrical limit protrusion 2594 conflicts with the left border 2331a of the arch window; when the limit protrusion 2594 conflicts with the right border of the arch window (picture omitted), it becomes
  • the central axis L2 of the guide passage 40 is coaxial with the central axis L1 of the venous catheter.
  • the extended portion 259 of the rigid part 25a of the sealing body is provided with a plurality of buckles 2593.
  • the buckles 2593 are inserted into the rectangular assembly holes 8341 on the connecting portion 834 of the lower shell member, thereby connecting the two into one body; 1
  • the fingers After pulling away, the fingers hold the main body of the lower shell component 83 and or the other parts of the shell assembly 8 connected to it to rotate, which can drive the sealing body 25 to synchronously rotate half a circle along the axis L3, changing from the initial state of FIG. 13A to the same as that of FIG. 13C.
  • FIG. 13C also shows the oblique groove 833 on the left side of the lower shell member 83, The needle tube base 16 is partially located in this inclined groove 833 before being pulled out.
  • Figure 13D also shows that after the needle tube 1 is withdrawn, the linear area 253 is closed and sealed to the outside, the needle tube seat 256 on the sealing body 25 is hollow, and the hollow plugging wire lumen 30 is provided with a guide wire 6, which is partially enlarged.
  • the booster wire 6 can be made of metal materials such as titanium alloy, stainless steel or hard PET, PA and other resins.
  • the setting of the assisting guide wire 6 increases the strength of the hollow plugging wire 3 and facilitates its forward movement.
  • the rear end of the rigid part 25a of the sealing body forming the guide passage 40 protrudes an extension 44.
  • the outer surface of the extension 44 is in sealing connection with the inner surface of the front end opening 51 of the bellows isolation member, and the end of the bellows isolation member 5 is connected Columnar control handle 53.
  • the upper end of the control handle 53 is provided with an assembly hole 532.
  • One side of the control handle 53 is connected with a fluid circulation part 54 that is easy to expand and deform; the rear end of the control handle 53 is connected with a corrugated guide wire isolation part 7
  • the proximal part 71, the assisted guide wire isolation part 7 and the distal part 72 of the assisted guide wire operating handle 73 stop at the cylindrical assisted wire operating handle 73.
  • the upper end of the operating handle 73 is provided with an assembly hole 730; the outer ring rib 832 of the lower shell member 83 is connected to the inner Between the annular ribs 831 is a circular accommodating groove 830, and the isolating member 5 and the auxiliary guide wire isolating member 7 are assembled to the accommodating groove 830 and the connecting cavity 8340 communicating with it.
  • the design of multiple grooves in the inner ring ribs 831 of the lower shell member 83 can reduce the weight of the material and reduce the production cost.
  • the center cavity 820 of the middle shell member 82 is sleeved on the inner ring rib 812 of the upper shell member.
  • the outer surface of the inner ring rib 812 is adjacent to the edge 8201 of the center hollow of the middle shell member.
  • the middle shell part 82 is provided with an arc window 821, and the manipulation handle 53 is sleeved in the arc window 821; the lower end surface 813 of the upper shell part 81 is provided with a fitting post 815, a fitting post 815
  • the arc-shaped window 821 of the middle shell part is inserted into the assembly hole 532 on the upper end surface of the manipulation handle 53, so that the upper shell part 81 is connected with the isolation part 5 and the plugging wire 3;
  • the lower end surface 823 of the middle shell part 82 is provided with a fitting post 826, The fitting post 826 is inserted into the assembly hole 730 on the upper end surface of the manipulation handle 73, so that the middle shell member 82 is connected with the assisting guide wire isolation member 7 and the assisting guide wire 6.
  • the lower end surface 823 of the middle shell component is adjacent to the upper end surface 8321 of the outer ring rib of the lower shell component, and the lower end surface 813 of the upper shell component is adjacent to the upper end surface 824 of the middle shell component; the upper end surface 843 of the assembly plate 84 is adjacent to the center of the lower shell component
  • the lower end surface 8302 of the annular boss of the cavity 8300 is adjacent, the assembly plate 84 is provided with a plurality of vertically upward buckles 841, and the assembly plate buckles 841 pass through the central cavity 8300 of the lower shell part and the central cavity of the middle shell part. 820.
  • the outward protrusions 8411 of the final assembly disk buckle are respectively inserted into the corresponding lateral assembly holes 8120 on the annular ribs 812 of the lower end surface 813 of the upper shell component, thereby assembling the shell assembly 8 into one body; the middle shell component 82, The upper shell part 81 can rotate relative to the lower shell part 83, and the middle shell part 82 and the upper shell part 81 can also rotate relative to each other.
  • the upper shell part 81 is connected with the assembly plate 84 to rotate synchronously;
  • the rotating upper shell member 81 drives the manipulation handle 53 located in the arc window 821 to rotate, the rotation range of the manipulation handle 53 stops between the proximal boundary 8212 and the distal boundary 8211 of the arc window 821;
  • the middle shell member The outer edge of 82 is provided with a plurality of toothed protrusions 825, and the middle shell member 82 rotates until the front end 8251 of the proximal toothed protrusion 825 collides with the inclined groove boss 8331 of the lower shell member 83 and the rotation stops.
  • the fitting column 815 of the upper shell member 81 passes through the arc window of the middle shell member 821 is embedded in the assembly hole 532 on the upper end of the control handle 53 (see 13G); the inserting post 826 of the middle shell member 82 is embedded in the upper end assembly hole 730 of the booster wire control handle 73; the proximal end of the middle shell member 82 is dented 825
  • the front end 8251 of the lower shell member 83 is far away from the oblique groove boss 8331 of the lower shell member 83; the front end 8252 of the dentate at the distal end of the middle shell member 82 abuts or is in close proximity to the right side boss 8342 of the lower shell member connecting portion 834; Fingers act on the dentate protrusion 825
  • Fig. 13G shows another angle cross-sectional view showing that the inner cavity 530 of the plugging wire manipulation handle communicates with the inner cavity 540 of the fluid circulation component in a coaxial state.
  • FIG. 13H The horizontal cross-sectional view of Fig. 13H shows that in the coaxial state, the control handle 73 is located at the position a, the guide wire end 62 is fixed therein, and the control handle 53 is located at the position c.
  • FIG. 13I rotate the middle shell component 82 clockwise according to the arrow.
  • the front end 8251 of the proximal dentate 825 of the middle shell component 82 abuts against the oblique groove boss 8331 of the lower shell component 83 and rotates into place; now as shown in Figure 13J
  • the partial cross-sectional view shows that the front end 311 of the blocking wire 3 travels to the rear opening 202 of the venous catheter, and the leading end 61 of the assisting guide wire is located in the top 311; at this time, the control handle 73 moves forward to the position b, and the control handle 53 moves forward to The position of point d is shown in the horizontal sectional view of Figure 13K.
  • This design can prevent the guide wire 6 from entering the intravenous catheter lumen 20 or the length of the entry is extremely small to ensure In the blocked state, the hollow front section 31 of the blocking wire will not significantly increase the flexibility of the venous catheter 2 and eliminate the additional damage to the venous wall; the containment groove 830 will protect the isolation component 5, the blocking wire 3 and the guide wire throughout the entire process.
  • the isolation component 7 and the auxiliary guide wire 6 play the role of guiding and limiting.
  • the solution of this example can realize sensitive blood return and needle tip protection during the needle insertion process.
  • the needle tube base 16 is provided with an inner cavity 160, and the bottom 15 of the needle tube is located in the inner cavity 160 of the needle tube base.
  • the rear end of the hard part 25a of the sealing body containing the needle tube 1 is provided with a tubular extension part 26, the inner cavity 260 of which accommodates part of the needle tube 1, the bottom part of the tubular extension part 26 of the sealing body is sleeved in the inner cavity 160 of the needle tube seat, and the bottom of the needle tube is 15 sets
  • a compression spring E that can drive the needle tube 1 to move axially relative to the venous catheter holder 23 is provided.
  • One end of the compression spring E abuts against the bottom of the inner cavity 160 of the needle tube holder, and the other end abuts against the bottom end surface 261 of the tubular extension 26.
  • a partial opening 262 is provided on the side; the compression spring E extends axially to push the bottom end 261 of the tubular extension 26 and the sealing body 25 together with the venous catheter socket 23 to move forward so that the venous catheter lumen front end opening 201 covers the sharp needle tip 111.
  • the needle tube base 16 is connected with a leaf-shaped handle 18, which extends to the right side 236 of the venous catheter base.
  • the front end of the leaf-shaped handle 18 is provided with a curved portion 182, as shown in FIG. 14B, the handle 18 is partially opened 262 in the tubular extension 26 of the sealing body
  • the corresponding area is provided with a pressing piece 181 with a horizontal cross section curved to the left
  • the needle tube seat 16 is also provided with a partial opening 161 in the area corresponding to the partial opening 262 of the tubular extension portion 26 of the sealing body, and the pressing piece free section 1811 It can be inserted into the partial opening 262 of the tubular extension of the sealing body through the partial opening 161 of the needle tube seat.
  • the compression spring E is compressed and the elastic potential energy is stored.
  • the sharp tip 111 of the needle tube protrudes from the front end opening 201 of the venous catheter, allowing for intravenous Puncture operation.
  • the finger P presses the flexible medical solution infusion connecting tube 24 to the upper surface of the handle 18 to make the connecting tube 24 partially concave and deform (the figure is omitted), and the finger P also inserts the free section 1811 of the handle pressing piece into the seal
  • the tubular extension 26 of the sealing body 25 is prevented from being pushed forward by the elastic force of the compression spring E.
  • the finger P When it feels that it enters the venous cavity V0, the finger P is slightly relaxed, and the connecting tube 24 is elastic.
  • the negative pressure attraction generated by the recovery actively draws blood from the venous cavity into the inner cavity of the needle tube.
  • the transparent venous catheter 2 can be used to observe whether there is blood return in the lateral opening 102 of the front end of the needle in time.
  • the sensitive active blood return function is effective for the blood in the venous lumen. It is especially important for patients with low pressure; after seeing the blood return, continue to relax the finger P to make the pressing piece 181 rebound, and its free section 1811 moves out of the local opening 262 of the tubular extension 26 of the sealing body, and the elastic potential energy of the compression spring E is released to push the sealing body 25.
  • the tubular extension 26 is connected with the venous catheter base 23 and the venous catheter 2 is moved forward, so that the front end opening 201 of the venous catheter lumen covers the sharp needle tip 111.
  • Fig. 14D shows that the venipuncture is successful, the needle tube 1 is withdrawn, and the infusion of medical solution can be started, and the blocking operation of the venous catheter 2 described in the previous embodiment can also be started.
  • the leaf-shaped handle 18 connected to the needle tube socket 16 can also be arranged on the upper end surface 233 or the left side surface 235 of the intravenous catheter socket; the free section 1811 of the pressing piece on the handle 18 may not be inserted into the partial opening 262 of the tubular extension 26 of the sealing body, but The frictional resistance generated by the close contact with the outer surface of the tubular extension 26 without opening can also oppose the elastic force of the compression spring E.
  • embodiment 14 adopts the blocking mechanism of embodiment 13, and its needle tube holder handle design is shown in Figure 15A.
  • the needle tube holder 16 is connected with left and right sides.
  • the left side of the connecting portion 192 of the handles 19a and 19b is provided with a rib-like notch 1920.
  • the notch 1910 and the rib-like notch 1920 can be inserted into the flexible medical solution infusion connecting tube 24; as shown in Figure 15B, the intravenous catheter holder
  • the upper end surface 233 is provided with upwardly extending longitudinally distributed ribs 2335.
  • the ribs 2335 are located in the gap 190. When the two fingers squeeze 19a and 19b to the center, the front end of the ribs 2335 is inside the beginning of the handle curved portion 191 The protrusion 1912 of the handle is blocked.

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Abstract

一种可封堵的静脉导管装置,包括用于刺破皮肤(S)及静脉壁(V)的针管(1),将针管底部(15)固定其内的针管座(16);静脉导管(2),与静脉导管后端开口(202)密封连接的静脉导管座(23);针管(1)穿过静脉导管座(23)上的密封体(25),针管前部(11)位于静脉导管内腔(20),针管前端(111)从静脉导管前端开口(201)露出;细长的可移动的封堵丝(3);将封堵丝(3)的一部分或全部与外部隔离的隔离部件(5);还包括导向通路(40),导向通路(40)至少前端为直管状部分(41);导向通路前端开口(401)直接或通过静脉导管座内腔(230)与静脉导管内腔(20)连通,封堵丝(3)可穿越导向通路(40)进入静脉导管内腔(20);导向通路(40)至少直管状部分(41)与静脉导管(2)同轴或可对外隔离的移动至其中心轴线(L2)与静脉导管中心轴线(L1)重合的位置;可与静脉导管座内腔(230)直接接触和/或流体连通的封堵丝(3)及导向通路(40)均与外部隔离。

Description

一种可封堵的静脉导管装置 技术领域
本发明涉及一种可封堵的静脉导管装置,属医疗器械技术领域。
背景技术
静脉穿刺及连带的静脉输注是临床各科室最为常用的一种通用技术,当输注时间较长时,最常使用柔性静脉导管留置在静脉管腔内,留置期间柔性的静脉导管消除了因刚性的针管前端刺穿静脉的风险;但是,无药液注入的留置期间静脉导管内及开口处因局部血流缓慢或血流停滞极易引发血液凝固,即使应用肝素等抗凝剂封管、生理盐水冲管等措施仍无法杜绝血栓在静脉导管内腔形成,而血栓的脱落会导致急性肺栓塞危及生命。
当患者肢体活动显著时,血液极易进入静脉导管内腔进一步加速了血栓的形成。
即使静脉导管内腔未形成血栓,导管开口处因局部血流缓慢或血流停滞亦会形成挂壁血栓或沿导管外表面延伸的纤维蛋白鞘,不仅堵塞静脉管腔也会引发邻近静脉内膜上的血栓形成。
专利申请201810470421.9提出通过封堵丝对外隔离的将静脉导管前端开口封堵,并通过导向辅助封堵丝顺利进入静脉导管内腔,但封堵丝在导向通路开口与静脉导管内腔后端开口之间行进为游离状态进行且无同轴导向的结构,封堵丝难以轻松的进入静脉导管内腔。
发明内容
本发明为了解决上述问题,提供了一种可封堵的静脉导管装置。
本发明的目的是这样实现的:
一种可封堵的静脉导管装置,包括:用于刺破皮肤及静脉壁的针管,将针管底部固定其内的针管座;静脉导管及与静脉导管后端开口密封连接的静脉导管座;针管穿过静脉导管座上的密封体,针管前部位于静脉导管内腔,针管前端从静脉导管前端开口露出;以及细长的可移动的封堵丝;将封堵丝的一部分或全部与外部隔离的隔离部件;还包括导向通路,导向通路至少前端为直管状部分;导向通路前端开口直接或通过静脉导管座内腔与静脉导管内腔连通,封堵丝可穿越导向通路进入静脉导管内腔;导向通路至少直管状部分与静脉导管同轴或可对外隔离的移动至其中心轴线与静脉导管中心轴线重合的位置;可与静脉导管座内腔直接接触和或流体连通的封堵丝及导向通路均与外部隔离。
所述静脉导管其功能指不仅可以注入无菌水、药液、血液等流体,也可将静脉血液、动脉血液、脑脊液、胸腔积液等体液抽出供检验使用,静脉导管为进出静脉、动脉、胸膜腔、蛛网膜下腔、腹腔等人体腔隙的双向通路。
所述导向通路可由密封体上贯穿的通孔直接构成;或是一中空的通路部件穿越密封体和或静脉导管座,通路部件内腔即为导向通路;导向通路也可由密封体上的通路和其它部件上的通路共同构成。
密封体整体呈圆柱状、条块状等与静脉导管座适形,由可形变的弹性材料或不易形变的硬质材料制成;密封体也可是与静脉导管座密封且易变形的弹性部分和含有导向通路的硬质部分共同构成;也可是与静脉导管座密封且不易变形的硬质部分和含有导向通路的易形变的弹性部分共同构成;密封体可完全由硬质材料制成与静脉导管座可旋转的密封连接,也可是硬质的主体外设弹性密封圈与静脉导管座可旋转的密封连接,截面形状优选为圆形,也可近似圆形或多边形。
为了便于封堵丝进入静脉导管内腔,导向通路至少一部分可延伸至静脉导管座内腔,甚至延伸至静脉导管后端开口。
封堵丝和导向通路静止或相对运动时可与静脉导管座内腔流体直接接触,静脉导管座内腔流体通过导向通路和封堵丝之间的间隙外溢并与封堵丝和导向通路接触即为所述的流体连通。
导向通路内表面可设有封堵丝静止或轴向运动时阻止流体外溢的凸起和或凹陷,其与封堵丝外表面形成过渡配合,允许气体通过不允许流体通过;其与封堵丝外表面形成过盈配合,既不允许流体通过,也不允许气体通过。
所述隔离部件可以是密封体延伸出的可形变的囊体结构;或为中空的薄壁的受力易于形变的可包括管状、袖套状、圆盘状、叶片状、蝶翼状、船桨状在内的对外密封的柔性隔离部件;或为中空的受力不易形变的可包括管状、圆盘状、叶片状、蝶翼状、船桨状在内的对外密封的硬质隔离部件;亦或为中空的薄壁的受力易于形变的柔性部分与中空的受力不易形变的硬质部分共同组成可包括管状、袖套状、圆盘状、叶片状、蝶翼状、船桨状在内的对外密封的隔离部件;其内腔可通过导向通路与静脉导管座内腔接触输注流体的部分相连通。
针管脱离静脉导管或完全抽离后,解除了针管对导向通路至少直管状部分包括旋转和或平移运动的约束,使得导向通路至少直管状部分的中心轴线可以移动至静脉导管中心轴线重合的位置,重合即是指二者共线及同轴,封堵丝更易于通过导向通路、静脉导管座内腔,进入静脉导管前端。
中心轴线位置重合后,从导向通路前端开口探出的细长的封堵丝更易于进入静脉导管内腔,最终将静脉导管前端开口封堵。
导向通路也可全部为直管状,也可直管状部分与其它直线部分有角度的连接,或与其它曲线形部分连接。
还包括输注连接管,输注连接管可与静脉导管座连接使输注连接管内腔可与静脉导管座内腔连通。
一种方案是输注连接管经由密封体与静脉导管座内腔连通,可使静脉导管座侧面无分支有利于使用时的胶贴与皮肤更好的接触,也可有助于减少或消除静脉导管座内腔中的死腔,也有助于使用生理盐水冲洗静脉导管座内腔时涡流的减少。
为了使导向通路前端开口更接近静脉导管后端开口,导向作用更为可靠,直管状的导向通路或导向通路直管状部分可对外隔离的朝向静脉导管做轴向移动。
一种功能合并的针管与封堵丝通路的方案是:导向通路至少直管状部分与静脉导管同轴,针管穿过导向通路直管状部分使针管前部位于静脉导管内腔;针管抽离后,封堵丝可经由导向通路直管状部分进入静脉导管内腔;同轴结构预先设置,省却了通过移动方能同轴的步骤。
另一方案是,设有不闭合的针管通路,针管通路穿过密封体,针管前部可经由针管通路前端开口从静脉导管前端开口露出;针管抽离后药液可经针管通路底端开口注入静脉导管座内腔。
为了通过平移方式使直管状的导向通路或导向通路直管状部分与静脉导管同轴,密封体设有可使导向通路对外隔离的位移的空穴。
空穴通过易于形变的薄膜与静脉导管座内腔隔离,薄膜可为密封体的一部分,也可是静脉导管座的一个连接部分,之前不同轴的导向通路部分可在针管抽离后平移至同轴位置,空穴为这种移动提供空间。
另一种通过移动而同轴的思路是,密封体或其上连有导向通路的部分与静脉导管座为可相对旋转的连接,密封体旋转轴线与静脉导管中心轴线平行;导向通路中心轴线与旋转轴线之间的垂直距离等于静脉导管中心轴线与旋转轴线之间的垂直距离。
为了更好的旋转,密封体上连有旋转手柄,静脉导管座上设有与旋转手柄配合的限位结构和或导向结构。
为了避免封堵丝在行进过程的弯曲,导向通路直管状部分的长度大于或等于其前端开口至静脉导管后端开口之间的距离。
为了确保封堵丝在静脉导管内腔不易因自身的弯曲造成推进困难,导向通路直管状部分的长度大于或等于静脉导管的长度的1/2。
进一步的可靠设计是,导向通路直管状部分的长度大于或等于静脉导管的长度。
更为可靠的,导向通路直管状部分的长度大于或等于其前端开口至静脉导管前端开口之间的距离。
导向通路与封堵丝外表面之间至少有一个环周区域为流体密封的接触,避免药液进入隔离部件内腔。
为了在隔离部件形变时容纳其内的气体,尤其对于波纹管状的隔离部件,封堵丝隔离部件相连有流体周转部件,隔离部件内腔与流体周转部件内腔流体连通。
为了便于驱动封堵丝及隔离部件移动,细长的封堵丝尾段连有操控柄,封堵丝隔离部件底端与操控柄的一部分密封连接,操控柄内腔设有流体周转部件,封堵丝隔离部件内腔与流体周转部件内腔流体连通。
为了减少封堵期间静脉导管的挠度增大对静脉管壁的压迫,细长的封堵丝至少前段中空从而形成封堵丝内腔,顶端为盲端;前段中空的封堵丝不会显著提升静脉导管的挠度。
一种封堵与药液输注通路的方案是,细长的封堵丝整体中空从而形成封堵丝内腔,末端设有开口,顶端为盲端,前段设有至少一个侧孔;当封堵丝前段回退至静脉导管座内腔时,药液可经末端设有开口进入封堵丝内腔再从侧孔流出,再经静脉导管注入静脉。
由于封堵丝外径总体较小而行进的距离较大,细长的封堵丝至少底段中空从而形成封堵丝内腔,其内腔可置入挠度较大但外径更小的可选择金属、碳纤维等材料的助推导丝。
助推导丝可进入封堵丝内腔推动封堵丝更好的前行,设置相应连接后也可辅助后退。
由于助推导丝挠度较大,静脉导管处于封堵状态时,助推导丝不进入静脉导管内腔或进入内腔的长度小于静脉导管长度的1/2。
助推导丝引导封堵丝顶端运动至静脉导管前端开口,随后可撤回助推导丝至初始位置或静脉导管后端开口处,或助推导丝在封堵丝封堵结束后随其一同撤回至初始位置。
助推导丝可辅助封堵丝顶端运动至静脉导管后端开口处,此时助推导丝停留在静脉导管后端开口处不再前行,再单独驱动封堵丝移动至静脉导管前端开口,此过程静脉导管作为封堵丝前行的导向。
助推导丝对封堵丝的辅助包括推动和或支撑。
中空封堵丝顶端也可设置成为非盲端,封堵丝顶端部分的外表面封堵静脉导管前端开口, 助推导丝的顶端部分封堵中空封堵丝的顶端开口。
封堵丝和助推导丝底端可分别连有一个便于外力施加的操控柄,封堵丝隔离部件底端直接或通过封堵丝的操控柄与封堵丝密封固定连接。
为进一步保证静脉导管装置在使用过程中是对外隔离的,将助推导丝也置于一隔离部件内,助推导丝可直接与该隔离部件底端固定连接,或通过助推导丝的操控柄与该隔离部件底端密封固定连接。
为了在静脉导管座外更好的操控封堵丝、助推导丝及隔离部件,还包括与导向通路相连的壳组件;壳组件可为长条状、圆盘状等,其内设置相应沟槽等容纳及导向结构;封堵丝、隔离部件至少部分适形的位于壳组件内。
为了静脉穿刺时使进入静脉管腔的锐利的针管前端在继续行进时能被静脉导管前端包覆,从而实现安全进针,针管座连有一可驱动静脉导管座进行轴向移动的弹力部件。
为配合弹力部件的使用,针管座连有前端弯曲的叶片状手柄,前端弯曲与手指相抵可消除弹力部件导致针管的后退。
进一步的,针管座连有延展至静脉导管座上端面的左右两个前端弯曲的叶片状手柄;静脉导管座上设有位于两个叶片状手柄之间的突出状或凹陷状的配合结构。
为了避免低温凝血,封堵丝和或导向通路上连有产热元件。
产热元件可为金属电热丝或经非直接接触的电磁感应而产热的元件;产热元件可埋设在中空的封堵丝内,封堵丝底端连接电源及电子控制模块,在封堵状态下使位于静脉管腔内的静脉导管尤其是顶端部分温度等同或高于静脉内血液温度,从而有效避免血液在静脉导管上凝固。
本发明中受外力作用的如旋转手柄等各种操控柄,可以是手工驱动,也可是包括电机在内的驱动装置驱动。
本发明的有益效果是:
1.封堵丝被连续导向或间断但同轴导向前提下顺利进入静脉导管内腔。
2.无药液输注的留置期间,封堵丝将静脉导管顶端开口完全封堵,血液无法进入静脉导管内腔,彻底消除静脉导管内腔血栓形成的风险。
3.封堵丝圆锥形的顶端在封堵状态下部分伸出静脉导管顶端开口,从而消除局部血流死腔,最大程度的减少了挂壁血栓、纤维蛋白鞘、静脉血栓的发生。
4.实现静脉穿刺过程中主动灵敏回血及安全进针功能。
5.至少设置在封堵丝顶端的产热元件可显著提升静脉导管顶端开口处的温度,最大程度避免血液凝固。
6.连通状态下,药液流经封堵丝顶端的产热元件不仅有利于人体热平衡的稳定也最大程度的避免血液因低温而凝固。
7.无论是连通或封堵状态,至少设置在封堵丝顶端的产热元件可避免因局部低温所致白细胞活性降低而导致感染的风险。
附图说明
并不局限本发明的附图如下:
图1A、1B、1C、1D、1E、1F:实施例1的结构示意图;
图2A、2B、2C、2D、2E、2F、2G、2H、2I:实施例2的结构示意图;
图3A、3B、3C、3D:实施例3的结构示意图;
图4A、4B、4C、4D、4E:实施例4的结构示意图;
图5A、5B、5C、5D、5E:实施例5的结构示意图;
图6A、6B、6C、6D:实施例6的结构示意图;
图7A、7B、7C、7D:实施例7的结构示意图;
图8A、8B、8C、8D、8E:实施例8的结构示意图;
图9A、9B:实施例9的结构示意图;
图10A、10B:实施例10的结构示意图;
图11:实施例11的结构示意图;
图12A、12B:实施例12的结构示意图;
图13A、13B、13C、13D、13E、13F、13G、13H、13I、13J、13K、13L、13M、13N:
实施例13的结构示意图;
图14A、14B、14C、14D:实施例14的结构示意图;
图15A、15B:实施例15的结构示意图;
具体实施方式
本发明中的附图标记在之前实施例有说明的,之后实施例标记不一定一一重复解释;并不局限本发明的实施例如下:
实施例1:
如图1A、1B、1C、1D、1E、1F所示,本发明的实施例1包括:用于刺破皮肤S及静脉壁V的刚性的针管1、针管座16、静脉导管2、静脉导管座23、密封体25、封堵丝3、封堵丝导向通路40、隔离部件5;针管1内部中空为针管内腔10,针管前部11位于静脉导管内腔20,穿刺时尖锐的针管前端111从静脉导管前端开口201露出;针管内腔10在针管前端设有开口101,针管前部11邻近针管前端111处设有侧向开口102;针管连接部12位于静脉导管座23前端231区域内,针管中部13位于静脉导管座内腔230,在密封体内的为针管穿越部14,针管底部15固定于针管座16内,针管座16连有一针管座手柄17;相对柔性的中空的静脉导管2可用PU、FEP等材料制成,由前部21及后部22组成,静脉导管前部21设有锥状变细的前端211,药液经由静脉导管内腔20从前端开口201流入静脉V,静脉导管内腔20通过后端开口202与静脉导管座内腔230连通;静脉导管座23前端231与后端232之间为上端面233、下端面234、左侧面235、右侧面236,其内腔230在前端231有一较小的前端开口2301及后端232有一较大的后端开口2302,前端开口2301内套设有中空的静脉导管后部22,静脉导管座后端开口2302内填塞有密封体25;静脉导管座左侧面235有一中空的输注侧支2351与连接管24相连,静脉导管座内腔230与连接管内腔240相通;密封体25前端面251邻接静脉导管座内腔230,后端面252朝外,密封体25由硬质部分25a及弹性部分25b连接而成,硬质部分25a可由树脂PC、AS、ABS等制成,弹性部分25b可由硅橡胶、聚氨酯等弹性材料制成,弹性部分25b可在针管1抽离后将其穿过的区域闭合并对外密封;密封体硬质部分25a内设有封堵丝导向通路40,导向通路40前段为直管状部分41,后段42与前段41倾斜连通,导向通路40设有前端开口401及后端开口402;细长的封堵丝3可从导向通路后端开口402进入导向通路40;封堵丝3外为一可形变的囊状薄壁的隔离部件5,可由硅橡胶、聚氨酯、聚乙烯、EVA、PET等柔性膜材制成,隔离部件前端51设有开口501,后端52为盲端,隔离部件前端51密封的套接于密封体25的硬质部分25a的圆柱状或扁平状的对外突出部254上,具体可通过粘接、热熔接、超声波焊接等方式密封连接,导向通路后段42的一部分位于此对外突出部254内,导向通路后端开口402位于此对外突出部254的后端面2541上;封堵丝3可能与静脉导管座内腔230直接接触和或流体连通的部分均位于隔离部件内腔50,本实施例封堵丝末端341完全位于隔离部件内腔50。
如图1A所示,针管1连带静脉导管2刺穿皮肤表面S、皮下组织S1、静脉壁V,尖锐的针管前端111进入静脉管腔V0,静脉血流入针管内腔10并在针管前端侧向开口102处被操作者透过透明的静脉导管2观察,从而用于确认穿刺的成功。
如图1B所示的初始状态下,针管中心轴线L0、导向通路直管状部分中心轴线L2、静脉 导管中心轴线L1三线共线,针管穿越部14的一部分14a位于密封体硬质部分25a的导向通路直管状部分41内,针管穿越部14的另一部分14b穿过密封体弹性部分25b;此时,导向通路前端开口401被针管穿越部分14a占用,封堵丝3无法进入静脉导管座内腔230。
如图1C所示,完成静脉穿刺后,将针管1抽离,密封体的弹性部分25b因材料的回弹形变将针管穿过的线状区域253闭合并对外密封,此时导向通路前端开口401与静脉导管座内腔230连通;如图1D所示,因导向通路直管状部分41与静脉导管2同轴,即导向通路直管状部分中心轴线L2与静脉导管中心轴线L1共线,封堵丝3在导向通路直管状部分41的同轴导向下进入静脉导管座内腔230;如图1E所示,封堵丝3经由静脉导管后端开口202进入静脉导管内腔20;如图1F所示,封堵丝3最终将静脉导管前端开口201封堵,隔离部件5发生形变向密封体25后端面252方向压缩堆积;这种同轴直进的设计使细长的封堵丝3更容易进入静脉导管内腔20,其效果远优于不同轴的斜进方式。
如图1F所示的封堵状态下,封堵丝3位于静脉导管内腔20的部分为前段31,位于静脉导管座内腔230的部分为中段32,位于导向通路直管状部分41内的部分为后段33,其余部分为尾段34,尾段34末端341位于隔离部件内腔50内,封堵丝前段31顶端311呈锥形渐细从静脉导管前端开口201内突出,最大程度消除了封堵期间此处的血液涡流;封堵丝顶端311与静脉导管前端开口201为血液阻隔的接触,即血液无法从二者间隙通过,可以是过盈配合也可是适形配合。
本实施例封堵丝3为实体的丝线状,可由树脂材料如PU、PA、PET、PDFE应用挤出或注塑工艺成型,也可选择镍钛合金等金属材质;使用时操作者手指P通过压捏住柔性薄膜状的隔离部件5从而固定位于其内腔50的封堵丝3,驱使封堵丝3前进或退后,具体可压捏住隔离部件后端52及其内的封堵丝尾段34末端341部分。
实施例2:
如图2A、2B、2C、2D、2E、2F、2G、2H、2I所示,与实施例1最大的不同是在初始状态下导向通路直管状部分41的中心轴线L2与静脉导管中心轴线L1不同轴但呈平行关系,图2A显示针管座16位于隔离部件5的下方,静脉导管座23上端面233设有拱形窗口2331,拱形窗口2331内露出密封体硬质部分25a的一部分,密封体硬质部分25a上连有手柄255,手柄255通过颈部2551与密封体硬质部分25a相连;图2B剖视显示封堵丝前段顶端311位于导向通路40内并邻近后端开口402,导向通路前端开口401对向静脉导管座内腔230的凸台2303,封堵丝3无法进入静脉导管内腔20;密封体硬质部分25a与弹性部分25b以二次注塑、粘接、过盈配合等方式相互交错的结合为一体,二者可同步运动;当静脉导管内腔20内无针 管1干涉时,驱动手柄255从拱形窗口2331左侧旋转至右侧,可使密封体25以静脉导管座23的中心线L3为轴线发生旋转位移;图2C显示针管1从密封体25抽离,线状区域253闭合并对外密封,密封体25上针管座凹陷256虚空,此时线状区域253仍位于静脉导管中心轴线L1延长线上;如图2D,操作者手指P作用于密封体硬质部分25a上的手柄255,驱动手柄255从拱形窗口2331左侧旋转至右侧,颈部2551无法移动时即旋转到位,此时直管状导向通路40的中心轴线L2与静脉导管中心轴线L1共线,如图2E所示,手指P在隔离部件5上施力可驱动封堵丝前段顶端311在静脉导管中心轴线L1上沿箭头方向前行;图2F示出封堵丝前段31顶端311呈锥形渐细从静脉导管前端开口201内突出,从而将静脉导管2封堵,隔离部件5整体轴向压缩向两侧形变;为清晰展示通过旋转移动的方式实现的同轴的原理,剖视图2G示出初始状态,针管1位于静脉导管内腔20,直管状导向通路40的中心轴线L2与静脉导管中心轴线L1不同轴但呈平行关系,旋转轴线L3位于二者中间;剖视图2H显示针管1从密封体25中抽出,此时无旋转移动的干涉因素;剖视图2I显示旋转到位后的状态,直管状导向通路40的中心轴线L2与静脉导管中心轴线L1处于共线位置,本实施例导向通路40全程笔直,无弯曲及倾斜部分,整个旋转动作在对外部环境隔离的前提下进行,无微生物或异物进入静脉导管座内腔230的风险;当需要静脉输注时仅需将封堵丝3从静脉导管内腔20拉出,使其不堵塞静脉导管后端开口202即可。
实施例3:
如图3A、3B、3C、3D所示,与实施例2通过对外隔离的旋转方式使密封体25上的直管状导向通路40的中心轴线L2与静脉导管中心轴线L1共线的方式最大区别在于,导向通路40由独立中空的通路部件4构成,且通过对外隔离的平移而非旋转的方式实现共线。
如剖视图3A,静脉导管座上端面233上有一管状突出部2332,管状突出部2332内套设通路部件4,通路部件4有一延伸段43从静脉导管座管状突出部外端面2333探出,隔离部件前端51内表面与管状突出部2332外表面密封连接,通路部件延伸段43位于隔离部件内腔50,通路部件4可被作用于延伸段43的外力驱动相对管状突出部2332位移,通路部件4弯曲的中空部分前段为导向通路直管状部分41,后段42与前段41倾斜连通,细长的封堵丝3其前段31部分的进入导向通路后段42内,导向通路直管状部分41的中心轴线L2与静脉导管中心轴线L1平行但不同轴,密封体25可完全由弹性材料制成且不必旋转;初始状态下,由于针管1的阻碍通路部件4无法向下移动。
使用时,当静脉穿刺成功后针管1开始从密封体25上抽离,如图3B所示针管1抽出后将不再阻碍通路部件4的下行。
如图3C,手指P压捏隔离部件前端51附近区域,使薄膜状的柔性的隔离部件5部分接触通路部件延伸段43并用力向下推送,通路部件4下行直至其直管状部分41的中心轴线L2与静脉导管中心轴线L1同轴,此时通路部件直管状部分41前端与静脉导管座内壁相抵无法继续移动。
如图3D,封堵丝前段31从导向通路前端开口401伸出沿静脉导管中心轴线L1前行进入静脉导管内腔20,由于可靠的隔离,外部环境的微生物和或其他异物不会因此操作被带入静脉导管座内腔230,也即不会进入静脉管腔V0;当然,静脉导管座23上的管状突出部2332也可设置在静脉导管座左侧面235或右侧面236上。
实施例4:
如图4A、4B、4C、4D、4E所示,与实施例3通过对外隔离的平移而非旋转方式将独立中空的通路部件4构成的导向通路直管状部分41的中心轴线L2移动至与静脉导管中心轴线L1同轴位置的方式最大区别在于,直管状的通路部件4、针管贯穿密封体弹性部分25b及密封体硬质部分25a与静脉导管座23内壁密封连接;邻近静脉导管座右侧面236,密封体弹性部分25b与硬质部分25a之间有一空穴257,右侧空穴257为形状体积恰可容纳弹性部分25b的针管1穿过的区域。
如图4B剖视所示,密封体弹性部分25b可相对硬质部分25a对外密封的平移,密封体弹性部分25b前端边缘通过柔性膜片与硬质部分25a前端边缘密封连接,图中示出密封膜片左侧部分25c呈弯折状,右侧部分25d相对舒展,而右侧的空穴257则由密封膜片右侧部分25d与静脉导管座内腔230隔离;通路部件4有一延伸段44从密封体弹性部分25b后端探出,延伸段44外表面与隔离部件前端51内表面密封连接;当无针管1干涉时,外力作用于通路部件延伸段44可使密封体弹性部分25b连带导向通路40平移。
如图4C剖视所示,当静脉穿刺成功后,将针管1从密封体弹性部分25b上抽离,针管1之前穿过的线状区域253闭合并对外密封,此时如外力作用于通路部件延伸段44可使密封体弹性部分25b连带导向通路40发生对外隔离的平移,如箭头所示。
如图4D剖视所示,密封体弹性部分25b连带导向通路40平移至右侧空穴257并将空穴257填充,而弹性部分25b之前的空间闲置形成左侧空穴258;密封膜片左侧部分25c舒展,而右侧部分25d相对之前则呈弯折状;此时,导向通路中心轴线L2与静脉导管中心轴线L1处于同轴位置。
如图4E,从导向通路前端开口401伸出的封堵丝3可顺利进入静脉导管内腔20,最终将静脉导管前端开口201封堵。
实施例5:
本实施例展示的方案是直管状导向通路40的中心轴线L2旋转移动至与静脉导管中心轴线L1共线的位置后,导向通路40轴向移动,最终使导向通路前端开口401更为接近或直接接触静脉导管后端开口202,从而更好的保障封堵丝3的进入。
图5A剖视显示针管1及通路部件4贯穿的位于密封体25内,针管座16的前端部分嵌入密封体25的凹陷256内,密封体25由硬质部分25a和弹性部分25b组成,通路部件4整体呈直管状,一个延伸部45从密封体硬质部分25a后端探出,包裹通路部件4的密封体硬质部分25a后端有一突出于静脉导管座后端232的延伸部分259,延伸部分259有薄壁的末端2591及手柄2592,延伸部分259薄壁的末端2591外表面与隔离部件前端51部分内表面密封连接。
如图5B剖视显示,当静脉穿刺成功后,将针管1从密封体弹性部分25b上抽离,针管1之前穿过的线状区域253闭合并对外密封,之前容纳针管座16的凹陷部分256虚空,此时外力作用于密封体硬质部分25a的延伸部分259或手柄2592,通过旋转位移使导向通路40中心轴线L2移动至与静脉导管中心轴线L1共线的位置,如图5C所示,此时封堵丝3可沿箭头指示的方向也即与静脉导管中心轴线L1同轴的方向移动。
如图5D剖视显示,为了确保封堵丝3沿导向通路40前行顺利进入静脉导管后端开口202,避免在经过静脉导管座内腔230时发生可能的偏斜,外力通过隔离部件5的外表面作用于通路部件4的延伸部45,使其对外隔离的轴向前移,直至导向通路前端开口401与静脉导管后端开口202对接,封堵丝3可顺利进入静脉导管内腔20;通路部件4在密封体硬质部分25a内的通道内平移,可以是密封接触前提下的平移;在通路部件4进入静脉导管座内腔230的部分设有一个或多个侧向开口403,当需要输注时,药液可经输注侧支(图略)进入静脉导管座内腔230再经此开口进入导向通路40及静脉导管内腔20,而无需将通路部件4退回。
如图5E剖视显示,封堵丝3可顺利进入静脉导管内腔20并将前端开口201封堵,封堵丝3的前行,全程均在直管状且连续的导向下进行。
实施例6:
如图6A、6B、6C、6D所示,本实施例6与实施例2的最大区别是密封体25上设有针管通路140,当针管1抽离后针管通路140不会闭合,而是通过阳性接头25e与药液输注的连接管24接头241对接,使连接管腔240内的药液流经针管通路140进入静脉导管座内腔230,继而进入静脉导管内腔20。
图6A剖视出初始状态下隔离部件5在上,针管座16在下,针管座手柄17延展在右侧,针管1位于硬质材料制成的密封体25内,针管座16部分的嵌入从密封体25后端面252上突 出的阳性接头25e内;直管状导向通路40的中心轴线L2与静脉导管中心轴线L1平行但不同轴。
图6B示出,当针管1抽离后,密封体25内的针管通路140显现,将连接管24前端的阴性接头241与阳性接头25e密封对接,即可启动药液沿箭头方向流入静脉导管内腔20。
图6C示出通过旋转操作使直管状导向通路40的中心轴线L2与静脉导管中心轴线L1共线,封堵丝3将静脉导管前端开口201封堵,静脉管腔V0内血液无法进入静脉导管内腔20,同时药液也无法进入静脉管腔V0;本例中导向通路40全程为直管状,未设置独立的部件而是由密封体25的内部通路形成。
图6D示出当封堵丝3回收至导向通路40内时,药液可沿箭头所示方向流入静脉导管内腔20。
实施例7:
如图7A、7B、7C、7D所示,与实施例6最大的不同在于密封体25后端设有连通管242,如图7A初始状态下,连通管242位于隔离部件5下方,连通管242设有侧支243,连通管侧支内腔2430可输注药液,连通管242底端连有接头244,接头244内装有弹性密封塞245,针管1穿越过弹性密封塞245、连通管内腔2420及密封体25内的针管通路140,针管座16连有手柄17位于接头244外。
如图7B,当静脉穿刺成功针管1抽离,弹性密封塞245上针管1穿过的线状区域2451闭合并对外密封,药液可经连通管侧支内腔2430、连通管内腔2420和或被输注针管(图略)刺穿的弹性密封塞245注入,药液沿图中箭头所示方向流入静脉导管座内腔230。
如图7C为通过对外隔离的旋转后的无药液输注的封堵状态,连通管242位于隔离部件5上方,连通管242底端连有接头244对外密封,连通管侧支243可连接输液管路或被输注接头封堵(图略)。
图7D所示,需再次进行药液输注时,药液可经位于隔离部件5上方的连通管侧支内腔2430、连通管内腔2420和或被输注针管(图略)刺穿的弹性密封塞245注入,药液沿图中箭头所示方向流入静脉导管座内腔230。
实施例8:
如图8A、8B、8C、8D、8E所示,本实施例方案强调输注药液的连接管24其内腔经由密封体25上的输注通路250而进入静脉导管座内腔230。
如图8A,针管座16位于隔离部件5的下方,输注药液的连接管24从密封体25后端面 252接入,静脉导管座23上端面233设有拱形窗口2331,拱形窗口2331内露出密封体硬质部分25a的一部分,密封体硬质部分25a上连有手柄255,手柄255通过颈部2551与密封体硬质部分25a相连。
不同局部剖视视角的剖视图8B与8C显示,封堵丝前段顶端311位于导向通路40内并邻近后端开口402,导向通路前端开口401对向静脉导管座23内壁,封堵丝3无法进入静脉导管内腔20;针管1抽离密封体25,之前容纳针管1的密封体弹性部分25b的线状区域253闭合并对外密封,硬质部分25a容纳针管座16的凹陷256虚空;此时药液可从连接管内腔240经由密封体25上的输注通路250而进入静脉导管座内腔230,再由静脉导管内腔20流入静脉。
图8D显示,当无静脉导管内腔20的针管1干涉时,驱动手柄255从拱形窗口2331左侧经右侧旋转270°至下侧,可使密封体25以静脉导管座23的中心线L3为轴线发生旋转位移;直管状导向通路40的中心轴线L2与静脉导管中心轴线L1共线。
图8E示出封堵丝前段31顶端311呈锥形渐细从静脉导管前端开口201内突出,从而将静脉导管2封堵,隔离部件5整体轴向压缩向两侧形变。
实施例9:
如图9A所示,直管状导向通路40的长度L8大于或等于其前端开口401至静脉导管后端开口202之间的距离L5,这样的设计可确保封堵丝3在直管状导向通路40的约束下同轴前行顺利进入静脉导管内腔20,静脉导管内腔20可继续对封堵丝3导向。
一种经试验证实的方案是直管状导向通路40的长度L8大于或等于静脉导管2的长度L6的1/2,这样可一定程度的避免使用弯曲的导向通路40时,弯曲部分对封堵丝3的塑形作用而使其进入静脉导管内腔20时产生阻力。
一种更为可靠的尺寸选择是,直管状导向通路40的长度L8大于或等于静脉导管2的长度L6,以确保封堵丝3在行进中不受导向通路40可能存在的弯曲部分的影响。
更为可靠的方案是,直管状导向通路40的长度L8大于或等于其前端开口401至静脉导管前端开口201之间的距离L7,这样即使是容易弯曲的细长的封堵丝3,在直管状导向通路40内进行塑形后,仍可确保顺利进入静脉导管内20。
图9B局部放大示出导向通路前端开口401内设有两圈环周凸起404,环周凸起404与封堵丝3外表面过盈接触,阻止静脉导管座内腔230的药液或血液从二者间隙进入隔离部件内腔50。
实施例10:
如图10A所示,与前述实施例最大的不同是,隔离部件后端52相连有中空的操控柄53,操控柄内腔530前端开口531套设有囊状的易于膨胀的流体周转部件54,流体周转部件内腔540经连通孔5054与隔离部件内腔50连通,本图中流体周转部件54尚未膨胀,封堵丝尾段34末端341被固定于操控柄内腔530前端开口531内。
如图10B,当手指(图略)驱动操控柄53使封堵丝3前行时,隔离部件5压缩形变,其内腔50的气体被压入膨胀的流体周转部件内腔540,避免气体压缩产生阻力干扰封堵丝3前行;操控柄53可为扁平状、柱状、椭球状等。
实施例11:
如图11所示,与前述实施例最大的不同是,细长的封堵丝3至少前段31中空从而形成封堵丝内腔30,顶端311为盲端;由于封堵状态下进入静脉导管内腔20的是封堵丝前段31,其内部中空可大大降低前段的挠度,从而避免与静脉导管2套叠后整体挠度的增加,减少封堵期间静脉导管2对静脉壁V可能的挤压损伤。
可以在封堵丝3前段31或封堵丝3整体设产热元件(图略)。产热元件可为金属电热丝或经非直接接触的电磁感应而产热的元件;在封堵状态下产热元件使位于静脉管腔V0内的静脉导管2尤其是前端211的温度等同或高于静脉内血液温度,从而有效避免血液在静脉导管2上凝固。
实施例12:
本实施例方案是使封堵丝内腔30可作为药液输注的通路。
如图12A所示,细长的封堵丝3中空从而形成封堵丝内腔30,封堵丝尾段34末端341设有开口3410,顶端311为盲端,前段31设有至少一个侧孔310;封堵丝末端开口3410连通于中空的操控柄55的内腔550;操控柄55前端551较细,前端551内部中空套设封堵丝尾段34部分,操控柄内腔550填充一弹性密封塞56;本图所示为针管1抽离后的封堵状态,静脉血无法逆流至静脉导管座内腔230;图中左侧放大图显示了封堵丝前段侧孔310紧邻静脉导管2内壁。
如图12B,需要输注药液时牵拉操控柄55使隔离部件5延展,封堵丝前段31从静脉导管后端开口202抽出,此时将外部针管刺入操控柄内腔550的弹性密封塞56输注药液(图略),则药液经由操控柄内腔550进入封堵丝内腔30,再如图中箭头所示从封堵丝前段侧孔310流入静脉导管座内腔230。
实施例13:
本例示出方案通过旋转而使导向通路40的中心轴线L2与静脉导管中心轴线L1共线的结构之前已详细描述,最大区别是封堵丝3、隔离部件5外套设有便于驱动的壳组件8,壳组件8的组成部分可精准控制封堵丝3及其内的助推导丝6的移动。
图13A、13B示出静脉导管座23结构大致与实施例2相同,初始状态下直管状导向通路40的中心轴线L2与静脉导管中心轴线L1不同轴但呈平行关系,针管座16位于隔离部件5的下方,静脉导管座23上端面233设有拱形窗口2331,拱形窗口2331内露出密封体硬质部分25a的一部分,不同的是密封体硬质部分25a后端有突出于静脉导管座后端面232的延伸部分259,延伸部分259上套接有壳组件8的下壳部件83的连接部834;壳组件8整体呈圆盘状,由下壳部件83、中壳部件82、上壳部件81及装配盘84组合而成;在图13A、13B所示的初始状态下,下壳部件83在上,中壳部件82居中,上壳部件81在下,装配盘84穿过下壳部件中心空洞8300;为增加稳定性,拱形窗口2331正中位置设有向上延展的前后纵向跨越的桥状的加强筋2334,密封体硬质部分25a上设有圆柱状限位凸起2594,圆柱状限位凸起2594不露出拱形窗口2331,圆柱状限位凸起2594与拱形窗口左侧边界2331a相抵;当限位凸起2594与拱形窗口右侧边界(图略)相抵时则变为导向通路40的中心轴线L2与静脉导管中心轴线L1同轴状态。
如图13D显示,密封体硬质部分25a延伸部分259设有多个卡扣2593,卡扣2593嵌入下壳部件连接部834上的矩形的装配孔8341,从而将二者连为一体;当针管1抽离后,手指把持下壳部件83主体和或与其相连的壳组件8其他部分转动,即可带动密封体25沿L3为轴同步旋转半周,从图13A的初始状态变为图13C的同轴状态,此时下壳部件83在下,上壳部件81居上,上壳部件上端面814上设有三个叶片状凸起811;图13C还示出下壳部件83左侧的斜行槽833,针管座16在抽离前,部分位于此斜行槽833内。
图13D还显示,针管1抽离后,线状区域253闭合并对外密封,密封体25上针管座凹陷256虚空,中空的封堵丝内腔30置有助推导丝6,局部放大部分显示助推导丝前端61与封堵丝前段顶端311内侧有一定间隙,当然也可完全相抵;助推导丝6可选用钛合金、不锈钢等金属材料或硬质的PET、PA等树脂制成,助推导丝6的设置增加了中空的封堵丝3的强度,便于其向前移动。
进一步的,形成导向通路40的密封体硬质部分25a后端探出一延伸段44,延伸段44外表面与波纹管状隔离部件前端开口部分51内表面密封连接,波纹管状隔离部件5末端连有柱状操控柄53,操控柄53上端面开有装配孔532,操控柄53一侧连有易于膨大形变的流体周转部件54;操控柄53后端连有波纹管状的助推导丝隔离部件7的近端部分71,助推导丝隔 离部件7远端部分72止于柱状的助推导丝操作柄73,操作柄73上端面开有装配孔730;下壳部件83外环凸筋832与内环凸筋831之间为圆环形容纳槽830,隔离部件5及助推导丝隔离部件7装配至此容纳槽830及与其连通的连接部内腔8340。下壳部件83内环凸筋831多个凹槽的设计可以减轻材料的重量,并降低生产成本。
如图13D与13E所示,中壳部件82的中心空洞820套装在上壳部件内环凸筋812上,内环凸筋812外表面与中壳部件中心空洞边缘8201邻接,所述邻接是可相对移动的接触或相接近;中壳部件82开有弧形窗口821,操控柄53套设在弧形窗口821内;上壳部件81下端面813上设有嵌合柱815,嵌合柱815经中壳部件弧形窗口821嵌入操控柄53上端面装配孔532内,从而使上壳部件81与隔离部件5及封堵丝3连接;中壳部件82下端面823设有嵌合柱826,嵌合柱826嵌入操控柄73上端面装配孔730内,从而使中壳部件82与助推导丝隔离部件7及助推导丝6连接。
进一步的,中壳部件下端面823与下壳部件外环凸筋上端面8321邻接,而上壳部件下端面813则与中壳部件上端面824邻接;装配盘84上端面843与下壳部件中心空洞8300的环形凸台下端面8302(见图13G)邻接,装配盘84设有多个竖直向上的卡扣841,装配盘卡扣841穿过下壳部件中心空洞8300、中壳部件中心空洞820,最终装配盘卡扣外向的突出部8411分别嵌入上壳部件下端面813的环状凸筋812上相对应的侧向装配孔8120内,从而将壳组件8装配一体;中壳部件82、上壳部件81均可相对下壳部件83相对旋转,中壳部件82、上壳部件81二者之间也可相对旋转;显然,上壳部件81是与装配盘84连为一体同步旋转;当旋转上壳部件81驱动位于弧形窗口821内的操控柄53旋转时,操控柄53旋转范围止于弧形窗口821近端边界8212与远端边界8211之间;为便于手指操作,中壳部件82外缘设有多个齿状突825,而当中壳部件82旋转至近端齿状突825的前端8251与下壳部件83的斜行槽凸台8331相抵时旋转停止。
如图13F局部剖视图所示,当针管1抽离,导向通路40的中心轴线L2与静脉导管中心轴线L1旋至同轴状态后,上壳部件81的嵌合柱815经中壳部件弧形窗口821嵌入操控柄53上端面装配孔532内(见13G);中壳部件82的嵌合柱826嵌入助推导丝操控柄73上端面装配孔730内;中壳部件82近端齿状突825的前端8251与下壳部件83的斜行槽凸台8331远离;中壳部件82远端端齿状突的前端8252与下壳部件连接部834的右侧凸台8342相抵或紧邻;此时,手指作用于中壳部件齿状突825按箭头指示顺时针旋转,可驱动助推导丝6及封堵丝3以圆弧形轨迹前移。
如图13G另一角度剖视图显示同轴状态下封堵丝操控柄内腔530与流体周转部件内腔540 连通。
如图13H水平剖视图显示同轴状态下,操控柄73位于a点位置,助推导丝末端62固定其内,操控柄53位于c点位置。
如图13I,按箭头指示顺时针旋转中壳部件82,中壳部件82近端齿状突825的前端8251与下壳部件83的斜行槽凸台8331相抵,旋转到位;此时如图13J局部剖视图显示,封堵丝3前段顶端311行进至静脉导管后端开口202,助推导丝前端61位于顶端311内;此时,操控柄73前行至b点位置,操控柄53前行至d点位置,如图13K水平剖视图显示。
如图13L,按箭头指示顺时针旋转上壳部件81,驱动封堵丝3继续前行,如图13M局部剖视图显示,封堵丝顶端311从静脉导管前端开口201探出达到封堵状态,位于容纳槽830内的波纹状的隔离部件5被显著压缩,此时,图中隔离部件5大部分位于连接部内腔8340内,而助推导丝隔离部件7则被最大程度拉伸;水平剖视图13N示出此时操控柄53前行至e点位置,而操控柄73仍位于b点位置,这种设计可使助推导丝6不进入静脉导管内腔20或进入的长度极小,以确保在封堵状态下中空的封堵丝前段31不会显著增加静脉导管2的挠度,消除因此可能对静脉壁的额外损伤;容纳槽830全程对隔离部件5、封堵丝3、助推导丝隔离部件7、助推导丝6起到导向及限位的作用。
解除封堵则需反向操作即可。
实施例14:
与之前实施例最大不同是本例方案可实现灵敏回血及进针过程的针尖防护,如图14A局部剖视图所示,针管座16设有内腔160,针管底部15位于针管座内腔160,参与容纳针管1的密封体硬质部分25a后端设有管状延伸部26,其内腔260容纳部分针管1,密封体管状延伸部26底端部分套设在针管座内腔160,针管底部15套设一可驱动针管1相对静脉导管座23进行轴向移动的压缩弹簧E,压缩弹簧E一端与针管座内腔160底部相抵,另一端与管状延伸部26底端面261相抵,管状延伸部26右侧设有局部开口262;压缩弹簧E轴向伸展推动管状延伸部26底端面261及密封体25连带静脉导管座23前移使静脉导管内腔前端开口201包覆锐利的针管前端111。
针管座16连有叶片状手柄18,叶片状手柄18延展至静脉导管座右侧面236,叶片状手柄18前端设有弯曲部182,如图14B,手柄18在密封体管状延伸部26的局部开口262相对应的区域设有向左弯曲的水平截面呈弧形的按压片181,针管座16也在密封体管状延伸部26的局部开口262相对应的区域设有局部开口161,按压片游离段1811可经针管座局部开口161嵌入密封体管状延伸部的局部开口262内,此种状态下压缩弹簧E被压缩,弹性势能储存, 锐利的针管前端111从静脉导管前端开口201探出,可以进行静脉穿刺操作。
穿刺时,如图14C,手指P将柔性的药液输注连接管24压向手柄18上表面使连接管24局部凹陷形变(图略),同时手指P也将手柄按压片游离段1811嵌入密封体管状延伸部的局部开口262内,阻止密封体25管状延伸部26被压缩弹簧E的弹力推动而前移,当感觉进入静脉管腔V0时将手指P轻微放松,连接管24被按压处弹性复原产生的负压吸引力将静脉管腔血液主动吸入针管内腔10,通过透明的静脉导管2可在针管前端侧向开口102及时观察有无回血,灵敏的主动回血功能对于静脉管腔内血液压力较低的患者尤为重要;见到回血后继续放松手指P使按压片181回弹,其游离段1811从密封体管状延伸部26的局部开口262内移出,压缩弹簧E弹性势能释放推动密封体25管状延伸部26连带静脉导管座23、静脉导管2前移,使静脉导管内腔前端开口201包覆锐利的针管前端111,由于手指P前部与手柄18前端弯曲部182相抵,阻止手柄18因压缩弹簧E伸展而后移,如图14A显示的状态,再继续向静脉管腔V0进针则不会刺穿静脉管壁V,从而实现安全进针。
图14D示出静脉穿刺成功,抽离针管1,可启动药液输注也可启动之前实施例描述的静脉导管2封堵操作。
针管座16相连的叶片状手柄18也可设置在静脉导管座上端面233或左侧面235;手柄18上的按压片游离段1811也可不嵌入密封体管状延伸部26的局部开口262,而是和无开口的管状延伸部26外表面紧密接触产生的摩擦阻力也可对抗压缩弹簧E的弹力。
实施例15:
为了更好的实现主动灵敏回血及安全进针,与实施例14不同的是:本例采用实施例13的封堵机构,并且其针管座手柄设计如图15A所示,针管座16连有左右两个前端弯曲的叶片状手柄19a、19b;手柄19a、19b在静脉导管座上端面233向上及左右两侧延展分布,二者之间留有空隙190;左侧手柄19a的弯曲部191边缘设有缺口1910,手柄19a、19b的连接部192的左侧设有凸筋状缺口1920,缺口1910、凸筋状缺口1920可嵌入柔性的药液输注连接管24;如图15B,静脉导管座上端面233设有向上延伸的纵向分布的凸筋2335,凸筋2335位于空隙190内,当两个手指向心用力挤压19a、19b时,凸筋2335前端被手柄弯曲部191起始处内侧的凸起1912阻挡,此时即使有压缩弹簧E推动也无法使静脉导管座23前移;而当手柄19a、19b在手指操控下向两侧移动时,手柄弯曲部191内侧的凸起1912则解除对凸筋2335的阻挡,此时如有压缩弹簧E推动可使静脉导管座23前移,由于手指P前部与手柄19a、19b前端弯曲部191相抵,阻止手柄19a、19b因压缩弹簧E(同实施例14,图略)伸展而后移,而起到与实施例14相同的作用。

Claims (26)

  1. 一种可封堵的静脉导管装置,包括:用于刺破皮肤及静脉壁的针管(1),将针管底部(15)固定其内的针管座(16);静脉导管(2),与静脉导管后端开口(202)密封连接的静脉导管座(23);针管(1)穿过静脉导管座(23)上的密封体(25),针管前部(11)位于静脉导管内腔(20),针管前端(111)从静脉导管前端开口(201)露出;以及细长的可移动的封堵丝(3);将封堵丝(3)的一部分或全部与外部隔离的隔离部件(5);其特征在于:还包括导向通路(40),导向通路(40)至少前端为直管状部分(41);导向通路前端开口(401)直接或通过静脉导管座内腔(230)与静脉导管内腔(20)连通,封堵丝(3)可穿越导向通路(40)进入静脉导管内腔(20);导向通路(40)至少直管状部分(41)与静脉导管(2)同轴或可对外隔离的移动至其中心轴线(L2)与静脉导管中心轴线(L1)重合的位置;可与静脉导管座内腔(230)直接接触和或流体连通的封堵丝(3)及导向通路(40)均与外部隔离。
  2. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:还包括输注连接管(24),输注连接管内腔(240)经由密封体(25)与静脉导管座内腔(230)连通。
  3. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:导向通路直管状部分(41)可对外隔离的朝向静脉导管(2)做轴向移动。
  4. 根据权利要求1所述的一种可封堵的静脉导管装置,导向通路至少直管状部分(41)与静脉导管(2)同轴,其特征在于:针管(1)穿过导向通路直管状部分(41)使针管前部(11)位于静脉导管内腔(20);针管(1)抽离后,封堵丝(3)可经由导向通路直管状部分(41)进入静脉导管内腔(20)。
  5. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:还包括穿过密封体(25)的针管通路(140),针管前端(111)可经由针管通路(140)从静脉导管前端开口(201)露出;针管(1)抽离后药液可经针管通路(140)注入静脉导管座内腔(230)。
  6. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:密封体(25)设有可使导向通路(40)对外隔离的位移的空穴(257)。
  7. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:密封体(25)或其上连有导向通路(40)的部分与静脉导管座(23)为可相对旋转的连接,密封体旋转轴线(L3)与静脉导管中心轴线(L1)平行;导向通路中心轴线(L2)与旋转轴线(L3)之间的垂直距离等于静脉导管中心轴线(L1)与旋转轴线(L3)之间的垂直距离。
  8. 根据权利要求7所述的一种可封堵的静脉导管装置,其特征在于:密封体(25)上连有旋转手柄(255),静脉导管座(23)上设有与旋转手柄(255)配合的限位结构和或导向结构(2331)。
  9. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:导向通路直管状部分(41)的长度(L8)大于或等于其前端开口(401)至静脉导管后端开口(202)之间的距离(L5)。
  10. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:导向通路直管状部分(41)的长度(L8)大于或等于静脉导管的长度(L6)的1/2。
  11. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:导向通路直管状部分(41)的长度(L8)大于或等于静脉导管的长度(L6)。
  12. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:导向通路直管状部分(41)的长度(L8)大于或等于其前端开口(401)至静脉导管前端开口(201)之间的距离(L7)。
  13. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:导向通路(40)与封堵丝外表面之间至少有一个环周区域(404)为流体密封的接触。
  14. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:还包括与封堵丝(3)隔离部件(5)相连的流体周转部件(54),隔离部件内腔(50)与流体周转部件内腔(540)流体连通。
  15. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:细长的封堵丝尾段(34)连有操控柄(53),封堵丝隔离部件底端(52)与操控柄(53)的一部分密封连接,操控柄内腔(530)设有流体周转部件(54),封堵丝隔离部件内腔(50)与流体周转部件内腔(540)流体连通。
  16. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:细长的封堵丝(3)至少前段(31)中空从而形成封堵丝内腔(30),顶端(311)为盲端。
  17. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:细长的封堵丝(3)中空从而形成封堵丝内腔(30),末端(341)设有开口(3410),顶端(311)为盲端,前段(31)设有至少一个侧孔(310)。
  18. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:细长的封堵丝(3)至少尾段(34)中空从而形成封堵丝内腔(30)。
  19. 根据权利要求18所述的一种可封堵的静脉导管装置,其特征在于:还包括可进入封堵丝内腔(30)推动封堵丝(3)前行的助推导丝(6)。
  20. 根据权利要求19所述的一种可封堵的静脉导管装置,其特征在于:还包括将助推导丝(6)的一部分或全部与外部隔离的助推导丝隔离部件(7)。
  21. 根据权利要求19所述的一种可封堵的静脉导管装置,其特征在于:静脉导管(2)处于封 堵状态时,助推导丝(6)不进入静脉导管内腔(20)或进入内腔的长度小于静脉导管长度(L6)的1/2。
  22. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:还包括与导向通路(40)相连的壳组件(8);封堵丝(3)、隔离部件(5)至少部分适形的位于壳组件(8)内。
  23. 根据权利要求1所述的一种可封堵的静脉导管装置,其特征在于:针管座(16)连有一可驱动静脉导管座(23)进行轴向移动的弹力部件(E)。
  24. 根据权利要求23所述的一种可封堵的静脉导管装置,其特征在于:针管座(16)连有前端弯曲的叶片状手柄(18)。
  25. 根据权利要求23所述的一种可封堵的静脉导管装置,其特征在于:针管座(16)连有延展至静脉导管座上端面(233)的左右两个前端弯曲的叶片状手柄(19a、19b);静脉导管座(23)上设有位于两个叶片状手柄(19a、19b)之间的突出状或凹陷状的配合结构(2335)。
  26. 根据权利要求1-25项任意一项所述的一种可封堵的静脉导管装置,其特征在于:封堵丝(3)和或导向通路(40)上连有产热元件。
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